Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed; luteinizing hormone-releasing hormone (LHRH) agonists and adjuvant bisphosphonate or denosumab use is allowed
Have testosterone <  ng/dL; patients must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy
Serum testosterone <  ng/dL; patients must continue primary androgen deprivation with a luteinizing-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy
Patients must have histologically documented adenocarcinoma of the prostate with progressive systemic (clinically metastatic disease documented on bone, CT, or magnetic resonance imaging (MRI) scan) disease despite castrate levels of testosterone (< ng/dL) due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist. Castrate levels of testosterone must be maintained.
Surgically or medically castrated. The testosterone levels do not need to be checked if the patient has undergone surgical castration for > months. Patients receiving chemical castration should have testosterone levels checked at baseline and confirmed to be in the castrate levels (<. ng/mL or . nM). In all cases the luteinizing hormone-releasing hormone (LHRH) antagonist/agonist is to be continued in these patients.
Castrate testosterone levels (<  ng/dL) achieved by orchiectomy or maintenance on a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
For all Parts except Part F and H: Participants must have either post-menopausal status or pre-menopausal status if continuing or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist such as goserelin.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within  days before the first dose of study treatment. Note: Subjects with prostate cancer currently receiving luteinizing hormone releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists may be maintained on these agents
Have received systemic anti-cancer treatment or radiotherapy less than  weeks before the first dose of AG-. Subjects with castration-resistant prostate cancer may continue therapy with a luteinizing hormone releasing hormone (LHRH) agonist while participating in this study. Continuation of supportive therapy with bisphosphonates or denosumab is also allowed, regardless of the underlying malignancy.
Age < and amenorrhea for  or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and follicle-stimulating hormone (FSH) value > milli-international units per milliliter (mIU/mL) and an estradiol value < picograms per milliliter (pg/mL) ( picomoles per liter [pmol/L]). Or ii. Premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting at least  weeks before the start of trial therapy and is planned to continue LHRH during the study.
Patients must not be on active luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy and must have testosterone level >  ng/dL
Testosterone =<  ng/dL; subjects must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy
intra-uterine hormone-releasing systems (IUSs),
Treated with continuous androgen ablative therapy (either surgical castration or luteinizing hormone- releasing hormone [LHRH] agonist/antagonist)
No other anticancer-therapy (chemotherapy, immunotherapy, hormonal anti-cancer therapy, radiotherapy [except for palliative local radiotherapy]), biological therapy or other novel agent is to be permitted while the patient is receiving study medication; patients on luteinizing hormone-releasing hormone (LHRH) analogue treatment for more than  months are allowed entry into the study and may continue at the discretion of the investigator
Subject has prior use of any hormones, including luteinizing hormone-releasing hormone (LHRH) agonists, ketoconazole, antiandrogens (such as bicalutamide, flutamide, or nilutamide), or -alpha-reductase inhibitors
If no prior orchiectomy has been performed, patients must remain on luteinizing hormone-releasing hormone (LHRH) agonist or antagonist (e.g. degarelix) therapy; patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of the antiandrogen, defined as two consecutive rising PSA values, obtained at least two weeks apart, or documented osseous or soft tissue progression; at least one of the PSA values must be obtained at least four weeks (flutamide) or six weeks (bicalutamide or nilutamide) after discontinuation
Part B: Participants must have advanced, recurrent, or metastatic breast cancer that is refractory to aromatase inhibitors (AI) with either disease recurrence or disease progression; must be hormone receptor positive (HR+) and human epidermal growth factor receptor  (HER)-negative; must be of postmenopausal status or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist
Prior surgical or chemical castration with serum testosterone <. nmol/L ( ng/dL). If the method of castration is use of a luteinizing hormone releasing hormone (LHRH) analogue,there must be a plan to maintain effective LHRH analogue treatment for the duration of the trial
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
Initiated  (+ ) days of androgen deprivation therapy (ADT) prior to day  of protocol therapy\r\n* Only luteinizing hormone-releasing hormone (LHRH) agonist treatment is considered ADT, bicalutamide or other antiandrogens used alone do not count
More than  month of prior hormone exposure or hormone exposure within  days of enrollment (up to  month of prior luteinizing hormone-releasing hormone (LHRH) agonist and/or anti-androgen therapy as neoadjuvant therapy prior to prostatectomy is allowed); prior enzalutamide, apalutamide, ketoconazole, abiraterone, or TAK for prostate cancer are prohibited; prior antiandrogen therapy (including but not limited to bicalutamide, flutamide, nilutamide, enzalutamide, and apalutamide) and prior estrogen therapy (including estrogen patch) are not allowed; all investigational agents are prohibited within  days of enrollment
Men who have had gonadotrophin releasing hormone (LHRH) agonist or antagonist hormone therapy in the prior six months
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (-alpha reductase inhibitors allowed), or LHRH agonists/antagonists (Note: LHRH allowed if begun within  month of day ).
No prior hormonal therapy with the exception of oral -alpha-reductase inhibitors (finasteride, dutasteride, etc.); patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.) must be off treatment for at least  weeks prior to enrollment; patients who have received prior luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy (leuprolide, goserelin acetate, etc.) are eligible provided serum testosterone is >  mg/dl
Patients who have had chemotherapy, radiotherapy, immunotherapy or anticancer agents within  weeks ( weeks for nitrosoureas or mitomycin C) of the first dose of study treatment, except hormonal therapy with luteinizing hormone-releasing hormone (LHRH) analogues for medical castration in patients with prostate cancer and breast cancer, which are permitted
Last dose of any antineoplastic therapy >=  weeks (including chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents); patients receiving hormone manipulation (e.g. selective estrogen receptor modulators [SERMs], aromatase inhibitors, luteinizing hormone releasing hormone [LHRH] agonist, etc.) for reasons other than treatment of metastatic breast cancer may continue this treatment at the discretion of the investigator
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists.
The following ongoing treatments are permitted:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Hormone therapy for primary prevention of breast cancer
Serum testosterone <  ng/dL; patients must continue primary anti-androgen therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy
Treatment naive, defined as less than  months of standard of care ADT (e.g. gonadotrophin releasing hormone [GNRH] agonist or antagonist with or without antiandrogen, including abiraterone) for metastatic hormone-sensitive prostate cancer prior to enrollment (at time of consent)
Treated with continuous androgen ablative therapy (either surgical castration or gonadotrophin releasing hormone [LHRH] agonist/antagonist) with documented castrate level of serum testosterone (<  ng/dl)
Ongoing androgen deprivation therapy (ADT) using an luteinizing hormone-releasing hormone (LHRH) agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed; OR screening serum testosterone must be =<  ng/dl
Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (<  ng/dL) within  months prior to registration
Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) \super-agonist\ or antagonist, or bilateral orchiectomy and serum testosterone level <  ng/dL (< . ng/mL, < . nmol/L) at screening.
Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (<  ng/dL) within  months prior to registration
The use of any prior hormones including luteinizing hormonereleasing hormone (LHRH) agonists, LHRH antagonists, antiandrogens such as bicalutamide, flutamide and nilutamide, and/or the use of -alpha reductase inhibitors, PCSPES (or PC-x product), megestrol acetate, or estrogen containing nutraceuticals within  months of\r\nstudy treatment initiation
Treatment within  days of cycle day: any other systemic therapy for prostate cancer (with the exception of luteinizing hormone-releasing hormone [LHRH] agonists and LHRH antagonists for testosterone suppression, and bisphosphonates and RANK-ligand inhibitors for bone metastases which are allowed); any other investigational product
Patients must be off prior chemotherapy, hormonal therapy, or biological therapy for at least  weeks or >  half-lives whichever comes first; patients with prostate cancer may continue to receive luteinizing hormonereleasing hormone (LHRH) agonist (unless orchiectomy has been performed)
Concurrent use of other anticancer agents or treatments, with the following exceptions:\r\n* Ongoing treatment with luteinizing hormone-releasing hormone (LHRH) agonists or antagonists, denosumab (Prolia) or bisphosphonate (eg, zoledronic acid) is allowed; ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within  days before the first dose of study treatment; note: subjects with prostate cancer currently receiving luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists may be maintained on these agents
Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists; serum testosterone must be at castrate levels (<  ng/dL) at least  days prior to registration
Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding  months prior to registration
Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)
Progressing on continuous androgen ablative therapy (either surgical castration or luteinizing hormone-releasing hormone [LHRH] agonist)
Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)
Ongoing androgen deprivation therapy (ADT) using a luteinizing hormone-releasing hormone (LHRH) agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed
Prior hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist/antagonist with or without antiandrogen) up to  weeks is permitted
Prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol [DES]), or bilateral orchiectomy
Androgen suppression therapy within past year; defined as: luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or androgen blocker, not -alpha reductase inhibitor
At least  days elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinizing Hormone-releasing Hormone [LHRH] or Gonadotropin-releasing Hormone [GnRH]), or resolution of all previous treatment related toxicities to CTCAE version . grade of ?  (except for chemotherapy induced alopecia and grade  peripheral neuropathy or grade  urinary frequency which are allowed). Prior major surgery must be at least  weeks prior to study entry.
Oestrogens, including hormone replacement therapy;
No other anticancer-therapy (chemotherapy, immunotherapy, hormonal anti-cancer therapy, radiotherapy [except for palliative local radiotherapy]), biological therapy or other novel agent is to be permitted while the patient is receiving study medication; patients on luteinizing hormone-releasing hormone (LHRH) analogue treatment for more than  months are allowed entry into the study and may continue at the discretion of the investigator
Surgically or medically castrated, with testosterone levels of <  ng/dL; if the patient is medically castrated, continuous dosing with luteinizing hormone-releasing hormone (LHRH) analogue must have been initiated at least  weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone including post-treatment follow up period
Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (<  ng/dL) within  months prior to registration
Non-pregnant and not nursing; women of childbearing potential must take the pregnancy test and must commit to receive luteinizing hormone-releasing hormone (LHRH) agonist Zoladex (goserelin) for two years starting from the commencement of the study medications
Surgically or medically castrated, with testosterone levels of <= nanograms per deciliter (ng/dL) (<. nanometer [nM]). If the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists/antagonists (patient who have not undergone orchiectomy) this therapy must have been initiated at least  weeks prior to Cycle  Day  and must be continued throughout the study.
Received hormonal therapy (apart from luteinizing hormone releasing hormone agonist/antagonist for prostate cancer and hormone replacement therapy) within  weeks prior to the first dose of study treatment
Received hormonal therapy (apart from luteinizing hormone releasing hormone agonist/antagonist for prostate cancer and hormone replacement therapy) within  weeks prior to the first dose of study treatment
TUMOR BIOPSY SEQUENCING: Patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment, denosumab, or similar agents areare eligible to participate and may continue this treatment; patients with prostate cancer may continue luteinizing hormone-releasing hormone (LHRH) agonists or antagonists
Prior history of up to  weeks of androgen deprivation therapy defined as luteinizing-hormone releasing hormone (LHRH) or other medical castration therapy prior to registration is acceptable; this will be in addition to the  months of ADT on study
Prior orchiectomy or must be on ongoing luteinizing hormone-releasing hormone (LHRH) agonist or antagonist (e.g., degarelix) therapy
Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone [LHRH] agonist; -alpha-reductase inhibitors) within the previous  months
Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
Has ongoing androgen deprivation with serum testosterone < ng/dL (<. nM). Treatment with luteinizing hormone-releasing hormone agonists or antagonists must have been initiated ? weeks prior to first dose of study therapy and must be continued throughout the study
Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within  days or  half-lives, whichever is longer, of study drug dosing ( weeks for nitrosoureas, mitomycin C, or molecular agents with t/ >  days); concurrent use of an luteinizing hormone releasing hormone (LHRH) agonist is permitted for all individuals and ongoing enzalutamide is required in Group .
Age <  years and surgical menopause with bilateral oophorectomy a. Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression at the time of screening. Long term use (> months prior to screening) is permitted
Prior therapy for prostate cancer (exceptions: luteinizing hormone-releasing hormone [LHRH] agonist or antagonist may have been initiated within  days prior to enrollment; bicalutamide may have been given within  days of enrollment as long as it has been stopped at least  days before enrollment and total duration was no longer than  days; previous alpha-reductase inhibitor use allowed IF patient has not been taking for at least  days prior to abiraterone acetate initiation, OR if alpha reductase inhibitor was not used as a primary treatment of prostate cancer and the PSA on alpha-reductase inhibitor remains within eligibility when doubled
Patients must not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started  month prior to enrollment on this study; in addition, men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists
EARLY INDUCTION GROUP: Subjects who have started androgen deprivation therapy (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with or without an anti-androgen agent) a maximum of  days before registration and who otherwise meet all the eligibility criteria.
LATE INDUCTION GROUP: Subjects who have NOT started any androgen deprivation therapy (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with or without an antiandrogen agent).
Patients with prior surgical or chemical castration with a serum testosterone of < ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the patient must be willing to continue the use of LHRH agonists during protocol treatment.
Have a history of uncontrolled pituitary hormone diseases that currently require varying doses of supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone [ACTH], growth hormone) or other endocrine disorders requiring varying doses of hormone administration with the exception of diabetes and osteoporosis
Castrate level of serum testosterone (<  ng/mL) achieved by prior hormonal therapy consisting of either a) orchiectomy or b) luteinizing hormone-releasing hormone (LHRH) agonists with or without an anti-androgen
Previous hormonal therapy such as luteinizing hormone releasing hormone (LHRH) agonists (e.g. goserelin, leuprolide), anti-androgens (e.g. flutamide, bicalutamide), estrogens (e.g. diethylstilbestrol [DES]), or surgical castration (orchiectomy)
Throughout the study, ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) analogue or prior bilateral orchiectomy (medical or surgical castration);
Subjects who are currently taking or have received hormones (eg, estrogen or progesterone) within  days the first dose of study drug. Note: Luteinizing hormone-releasing hormone (LHRH) analogs are permissible.
Have had either surgical castration OR be on luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with serum testosterone <  ng/dl AND agree to stay on LHRH agonist or antagonist therapy during the study
Receiving hormone replacement therapy, tamoxifen, or raloxifene within  months of trial entry; patients on non-systemic hormone replacement therapy are eligible
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, ARN- and others), cytochrome P, family  (CYP) inhibitors (including abiraterone, TAK-, galeterone, ketoconazole, and others), estrogens, luteinizing hormone-releasing hormone (LHRH) agonist/antagonists; topical ketoconazole and other topical antifungal agents are allowed; prior therapy with alpha-reductase inhibitors is allowed; LHRH therapy allowed if begun within  weeks of day \r\n* Prior androgens are allowed if the patient had a testosterone within the normal range prior to starting androgens and the androgens have been stopped for at least  days
The subject must have castration-resistant prostate cancer (CRPC) with castrate levels of serum testosterone less than  ng/dL; Note: subjects must maintain a castrate state; if they have not had an orchiectomy must continue to receive luteinizing-hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists unless intolerant
Castration resistant prostatic adenocarcinoma; subjects must have castrated levels of serum testosterone (<  ng/dL) achieved by orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy
Patients with rising PSA must have had either ) prior definitive therapy including surgery or radiation therapy (hormone-nave, defined as hormone-nave patients and patients who received hormone therapy in the past who currently have total testosterone greater than  ng/dL), or ) hormone suppressive therapy as documented by surgical castration or a serum testosterone value less than  ng/dL (hormone-independent). Patients must have completed these therapies for at least  months but no longer than  years prior to enrollment
Currently on androgen ablation hormone therapy (a luteinizing hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with testosterone level <  ng/dL)
Patients must have a one week washout period from prior hormonal therapy (e.g. testosterone, estrogen, progestin, gonadotropin-releasing hormone antagonist)
Participants without orchiectomy must be maintained on luteinizing-hormone-releasing hormone (LHRH) agonist/antagonist therapy
Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate
Surgically or medically castrated, with testosterone levels of <  ng/dL (< . nM); if the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least  weeks prior to cycle  day  and must be continued throughout the study
Patients must not have previously received hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist, antiandrogen, or both), with the exception of neoadjuvant or adjuvant hormones given in conjunction with prostatectomy; in such cases, hormone therapy must have been administered for =<  months, discontinued >=  months ago, and serum testosterone must be >=  ng/dL
Participants without orchiectomy must be maintained on luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy
Ongoing androgen-deprivation therapy (ADT) using a luteinizing hormone-releasing hormone (LHRH) agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed; screening serum testosterone must be =<  ng/dl
Prior androgen deprivation with luteinizing hormone-releasing hormone (LHRH) is permitted provided that testosterone levels prior to study entry have recovered to normal limits per reference laboratory
Newly diagnosed androgen-dependent prostate cancer; patients already on androgen-dependent therapy (ADT) are eligible as long as the time from initiation of luteinizing-hormone-releasing hormone (LHRH) analog or antagonist is not greater than  months
Have testosterone <  ng/dL; patients must continue primary androgen-deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue if they have not undergone orchiectomy
Patients on bisphosphonates for any cancer or on hormone therapy for prostate cancer will not need to discontinue this therapy to be eligible; however, patients with prostate cancer will need to have metastatic prostate cancer that has progressed despite hormonal therapy; castrate testosterone levels occur within hours after castration and within  to  weeks of a luteinizing hormone-releasing hormone agonist; the current standard is to continue androgen suppression despite progressive disease
For cohorts , , and  only: current or prior hormonal therapy (e.g., gonadotropin hormone releasing analogs, megestrol acetate, or antiandrogens) are exclusionary
A PSA of > . ng/ml after - months of androgen suppression therapy, which may consist of luteinizing hormone-releasing hormone (LHRH) agonist or antagonist alone or the combination of an LHRH agonist or antagonist plus an antiandrogen, such as bicalutamide; androgen suppression therapy will continue without interruption
I . Effective castration (serum testosterone levels ?. ng/mL) by orchiectomy and/or luteinizing hormone-releasing hormone (LHRH) agonists or antagonist with or without anti-androgens.
Serum testosterone levels <  ng/dL (unless surgically castrate); patients must continue androgen deprivation with an luteinizing hormone releasing hormone (LHRH) agonist if they have not undergone orchiectomy
The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
No therapy modulating testosterone levels (such as luteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within  months prior to enrollment; agents such as alpha-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids (replacement doses of steroids are allowed), PC-SPES, Saw Palmetto are not permitted at any time during the period that the PSA values are being collected
> days post hormone therapy usages, subjects who have or are currently undergoing hormone therapy (GnRH agonist/antagonist) must discontinue hormone therapy and go through a  day washout period prior to consideration for study participation, and must remain off hormone therapy throughout the duration of the follow-up period ( years);
No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy; patients may have received up to  months of androgen deprivation therapy (luteinizing hormone releasing hormone [LHRH] agonists, antiandrogens, or both) prior to being enrolled on the study
Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or bilateral orchiectomy and serum testosterone level <  ng/dL (< . ng/mL, < . nmol/L) at screening
Castrate testosterone levels at screening with continued Luteinizing hormone-releasing hormone (LHRH) therapy
Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
Has not received systemic therapy for prostate cancer (i.e. luteinizing-hormone-releasing hormone [LHRH] agonist/antagonist therapy)
Postmenopausal; use of luteinizing hormone-releasing hormone (LHRH) agonist permitted
Concurrent use of other anticancer agents or treatments except luteinizing hormone-releasing hormone (LHRH) antagonists, LHRH agonists, zoledronic acid and other bone targeting agents
=<  regimens of cytotoxic chemotherapy prior to study entry; retinoids, vitamin D analogues, peroxisome proliferator-activated receptor (PPAR) gamma agonists or antagonists, antiandrogens, progestational agents, estrogens, prostate cancer (PC)-SPES, luteinizing hormone-releasing hormone (LHRH)-analogues, vaccines, cytokines will not be considered \cytotoxics\; patients who have previously received ketoconazole + glucocorticoids will be eligible for this trial
Progressive metastatic prostate cancer (positive bone scan or measurable disease) despite castrate levels of testosterone (either from orchiectomy or luteinizing hormone-releasing hormone [LHRH] agonist therapy)
Hormonal anticancer therapies except for LHRH antagonists or LHRH agonists in hormone-refractory prostate cancer
Received anti-cancer therapy, including antibody, retinoid, or hormonal treatment (except megestrol acetate as supportive care), and radiation, within  weeks before dosing. Prior and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin and analogs for neuroendocrine tumors are permitted
Testosterone level <  ng/dL; patients receiving luteinizing hormone-releasing hormone (LHRH) agonists or antagonists must be continued to maintain castrate levels of testosterone while on study
Patients must have had evidence of disease progression while receiving primary androgen suppression therapy by orchiectomy or other primary hormonal therapy and abiraterone (specifically, patients can have received multiple prior additional androgen axis targeting agents including enzalutamide, and prior chemotherapy, but must have had progression while receiving abiraterone either currently or in the past)\r\n* Patients currently on abiraterone may continue with the start of the study drug(s)\r\n* Patients may continue luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist (e.g. aberelix); patients who have not undergone bilateral orchiectomy may continue LHRH therapy while on protocol
Prior androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist and/or antagonist allowed for either (neo)adjuvant treatment with local therapy or for biochemical relapse
Any type of systemic anticancer agent (including investigational) within  weeks of first dose of study treatment, or within  half-lives of the agent whichever is shorter; subjects on luteinizing-hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists may be maintained on these agents
Surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone
Have discontinued previous treatments for cancer and recovered from the acute effects of therapy (for example, at least  days for mitomycin-C or nitrosoureas,  days for other chemotherapy and biologics. At the discretion of the investigator, hormone refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy and breast cancer patients who are stable on antiestrogen therapy (for example, an aromatase inhibitor) may continue treatment
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
Ongoing systemic therapy (other than a luteinizing hormone-releasing hormone agonists [LHRH] agonist/antagonist) for prostate cancer including, but not limited to:\r\n* CYP- inhibitors (e.g. ketoconazole, abiraterone)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. ARN-)\r\n* Immunotherapy (e.g. sipuleucel-T)\r\n* Chemotherapy (e.g. docetaxel, cabazitaxel)\r\n* Radiopharmaceutical therapy (e.g. radium-, strontium-, samarium- )
NOTE: use of luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin) is not allowed
Use of any of the following medications within the past  months: testosterone, dehydroepiandrosterone (DHEA), estrogens, gonadotropin-releasing hormone (GnRH) analogs, antiandrogens, spironolactone, ketoconazole, recombinant human growth hormone (rhGH), megestrol acetate, prednisone  mg daily or equivalent doses of other glucocorticoids for more than two weeks
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, apalutamide and others), CYP inhibitors (including abiraterone, TAK-, galeterone, ketoconazole, and others), estrogens, luteinizing hormone releasing hormone (LHRH) agonist/antagonists; prior therapy with -alpha-reductase inhibitors is allowed; LHRH therapy allowed if begun within  weeks of day ; up to  days of bicalutamide is allowed if it is stopped two weeks prior to day 
Men >  diagnosed with prostate cancer for which antiandrogen therapy (ADT) (castration therapy) is being prescribed for at least  weeks; castration may be achieved surgically or using gonadotrophin releasing hormone (LHRH) agonists (i.e. leuprolide, goserelin, etc.) or LHRH antagonists (i.e. degarelix)
Hormone replacement therapy in the last three months
Medical indication for androgen deprivation therapy (ADT) via luteinizing hormone-releasing hormone (LHRH) analog +/- oral anti-androgen
Histologically documented adenocarcinoma of the prostate with systemic bone or node metastatic disease despite castrate levels of testosterone (<  ng/dL) due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist; castrate levels of testosterone must be maintained while on study; men can be enrolled prior to starting abiraterone and/or enzalutamide OR already be receiving treatment with abiraterone and/or enzalutamide
PROSTATE CANCER: Patients who are initiating any chemotherapy (examples are docetaxel, cabazitaxel, etc.) and/or hormone directed treatment for prostate cancer; examples of hormone directed therapy include gonadotropin releasing hormone (GnRH) agonist or antagonists (such as leuprolide, goserelin, triptorelin, histrelin and degarelix), androgen receptor blockers (such as bicalutamide or enzalutamide), or androgen biosynthesis inhibitors (such as abiraterone)
Second malignancies are allowed as long as the disease does not require active treatment with concomitant systemic cytotoxic chemotherapy, investigational or biologic therapy (e.g., anti-cytotoxic T-lymphocyte-associated protein  [CTLA] or human epidermal growth factor receptor  [HER] monoclonal antibodies); hormone-related therapies (e.g., gonadotrophin releasing hormone (LHRH) agonists, tamoxifen, etc.) are allowed
Receiving or planning to receive androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
Arm  patients may not have received any prior luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists, antiandrogens, or chemotherapy for their prostate cancer; treatment with -alpha reductase inhibitors (finasteride, dutasteride) are allowed
Have been previously diagnosed with a malignant solid tumor, completed their required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of  months or longer; chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti-luteinizing hormone releasing hormone (LHRH) therapy for prostate cancer in men will be permitted
Taking luteinizing hormone-releasing hormone (LHRH) agonists, androgen receptor blocking agents, finasteride, or has undergone bilateral orchiectomy
Documentation of menopausal status: postmenopausal subjects or pre-menopausal subjects with ovarian radiation or concomitant therapy with a luteinizing hormone-releasing hormone (LH-RH) agonist/antagonist are eligible.
Have testosterone <  ng/dL; patients must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH)/GnRH analogue (agonist or antagonist) if they have not undergone orchiectomy
Patients must not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); in addition, men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists
Treatment with chemotherapy, hormone therapy, or other investigational therapy within  weeks of first study doses; patients with non-adenocarcinoma of the prostate who may be on luteinizing hormone-releasing hormone agonist/antagonist therapy may continue use
Hormone replacement therapy within the last  months
Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression
Patients must have castrate levels of testosterone (<  ng/dL) on luteinizing hormone-releasing hormone (LHRH) analogue or have had prior bilateral orchiectomy, with evidence of castration-resistant disease by Prostate Cancer Working Group  (PCWG) criteria
Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone; (note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone [LHRH] agonists [Lupron or Trelstar], other anti-androgens, and/or abiraterone or enzalutamide may be in use)
Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone releasing hormone [LHRH] agonist; -alpha-reductase inhibitors) within the previous  months
The subject has biopsy-proven adenocarcinoma of the prostate with intermediate to high risk disease by University of California, San Francisco (UCSF) Cancer of the Prostate Risk Assessment (CAPRA) scoring and possesses a Gleason  component to the tumor; subjects will be enrolled either prior to radical prostatectomy (N=) or prior to initiation of androgen deprivation therapy (luteinizing hormone-releasing hormone [LHRH] agonist +/- antiandrogen) followed by definitive radiation therapy as their primary treatment for prostate cancer (N=)
Patients may receive no other concurrent anticancer treatments such as chemotherapy, hormone therapy (except for prostate cancer patients on luteinizing hormone-releasing hormone ((LHRH)) agonists), immunotherapy, biological agents, investigational agents, or radiation therapy during this trial, and should be off these treatments for at least  weeks, or until they have completely recovered from the side effects of these treatments, whichever is longest, except for persistent grade  neuropathy in patients who received prior platinum or taxanes.
Premenopausal women will be considered eligible for study participation if they are receiving medical ovarian suppression with luteinizing hormone-releasing hormone (LHRH) agonists with documented estradiol blood levels in their respective postmenopausal ranges.
Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding  months prior to registration