Testosterone > 50 ng/dL within 90 days prior to Step 1 registration
Serum testosterone concentration ?50 ng/dL sustained by medical or surgical castration Parts A,B or D (TNBC)
Serum testosterone concentration ?50 ng/dL sustained by medical or surgical castration.
Serum testosterone <50 ng/dL
Currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin), oxymetholone, danazol, fluoxymesterone (Halotestin), or testosterone-like agents.
Serum testosterone level < 50 ng/mL
Serum testosterone ? 50 ng/dL
Surgically or medically castrated, with testosterone ? 50 ng/dL (? 1.7 nmol/L).
Testosterone level =< 100 ng/dL
Serum testosterone < 50 ng/ml
Screening serum testosterone > 150 ng/dL
Be surgically or medically castrated, with serum testosterone levels of ? 50 ng/dL (1.73 nM)
Subjects must be receiving antiandrogen therapy (ADT) with a GnRH agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be < 50 ng/dL at enrollment; subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain < 50 ng/dL for the entire duration of study participation; subjects who have undergone orchiectomy are also eligible
Testosterone level < 50 ng/dL
Patient must have hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL within 12 weeks prior to randomization
Serum testosterone level < 50 ng/dL at screening
Testosterone =< 50 ng/dL
Not a candidate for standard effective therapy NOTE: In men with prostate cancer, baseline testosterone levels must also be ?50ng/dL (? 2.0nM) and surgical or ongoing medical castration must be maintained throughout the duration of the study.
Serum testosterone of 150 ng/dL or greater (if initial T is < 150 it can be repeated [recommended before 10 AM] and if > 150 patient will be considered eligible). If patient was on testosterone supplementation, testosterone measurements need to be obtained > 4 weeks off supplements
Serum testosterone > 200 ng/mL
Does not have castration resistant disease\r\n* Castration resistance defined as progression of disease despite serum testosterone level of < 50 ng/dL
Serum testosterone level =< 50 ng/dL at the screening visit
Baseline testosterone >= 100 ng/dl
Testosterone level ? 100 ng/dL
Asymptomatic or symptomatic hormone naive men with testosterone levels >= 100 ng/dL with previously treated localized prostate cancer who now have rising PSA’s and five or fewer bone metastases
Men with baseline serum testosterone < 100 ng/dL
Serum testosterone > 150 ng/dL. For patients treated up to 1 month of LHRH agonist, a testosterone measurement prior to the LHRH treatment will be used to determine eligibility, and must have been > 150 ng/dL. If no testosterone level is available from before LHRHa injection up to 30 days prior to study entry, the patient will be ineligible.
Surgically or ongoing medically castrated, with baseline testosterone levels of =< 50 ng/dL =< 2.0 nM).
Eugonadal state (serum testosterone > 150 ng/dL).
Serum testosterone ? 1.73 nmol/L (50 ng/dL) at screening.
Has a serum testosterone at the Screening visit of ? 150 ng/dL (5.2 nmol/L);
Serum testosterone >= 150 ng/dl
Baseline testosterone > 150 ng/dL if patient has not initiated hormonal therapy; for those patients who have already initiated hormonal therapy, baseline testosterone is not required
Serum testosterone >= 150 ng/dL
Serum testosterone >= 150 ng/dL
Surgically or ongoing medically castrated, with baseline testosterone levels of =< 50 ng/dL (=< 2.0 nM)
Requires estrogen or testosterone
Ongoing androgen deprivation with serum testosterone < 50 ng/dl
Patients may be receiving continuous hormonal ablation with surgical or medical castration with baseline testosterone < 50ng/dL
Serum testosterone >= 100 ng/dL
Bilirubin < 2.0 ng/dl
Creatinine < 3.0 ng/dl
Serum testosterone levels < 50 ng/L after surgical or continued chemical castration
Patients must have ongoing therapy to maintain serum testosterone < 50 ng/dL
Androgens (testosterone, dihydroepiandrosterone, etc.);
Testosterone =< 50 ng/dL (documented at any time while on LHRH agonist or antagonists or s/p orchiectomy)
Castration levels of testosterone defined as =< 50 ng/dL at study enrollment; must be at least 3 months from surgical castration or must have received medical castration therapy for at least 3 months and be receiving such therapy at the time of confirmed disease progression
Serum testosterone ? 150 ng/dL (5.2 nmol/L).
Testosterone ? 50 ng/dL (? 1.73 nmol/L) at screening;
Known serum testosterone =< 150 ng/dl or symptoms of hypogonadism (fatigue, hot flashes, hair loss, loss of muscle mass, osteoporosis, low libido, depression) prior to ADT initiation not explained by other medical co-morbidity OR history of testosterone supplement; if questionable, serum testosterone level greater than 150 ng/dl can be used to exclude hypogonadism
Specific eligibility criteria for Part 2 CRPC expansion cohort: Ongoing androgen deprivation therapy with a serum testosterone level <1.7 nanomoles/L or <50 ng/dL.
Patients must have a serum testosterone < 50 ng/dL demonstrated within 1 month of study entry
Be surgically or medically castrated, with serum testosterone levels of ? 50 ng/dL (1.73 nM)
Testosterone or testosterone-like agents (methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, dehydroepiandrosterone, androstenedione) other androgenic compounds or anti-androgens within 30 days prior to day 1 of protocol therapy
Testosterone >= 125 ng/dL
Baseline testosterone >= 100 ng/dl
Serum testosterone levels less than (<) 50 nanogram per deciliter (ng/dL) determined within 4 weeks prior to start of study drug
Patients must have a serum total testosterone level >= 150 ng/dL at the time of enrollment within 4 weeks prior to randomization
Testosterone ? 1.73 nmol/L (? 50 ng/dL) at screening;
Hypogonadism or severe androgen deficiency as defined by screening serum testosterone < 200 ng/dL
Surgically or medically castrated, with testosterone levels of less than (<) 50 nanogram per deciliter (ng/dL)
Castration-resistant prostate cancer: patients must have surgical or ongoing chemical (androgen deprivation therapy) castration, with baseline testosterone level =< 50 ng/dL determined within 4 weeks of starting study drug
Medical or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L).
Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL below the normal range for the institution
Participants must have a testosterone level < 50 ng/dL
Serum testosterone level: ? 50 ng/dL (1.7 nmol/L)
Testosterone =< 50 ng/dL (1.7 nmol/L)
Participants must have a testosterone levels < 50 ng/dL
Testosterone >= 50 ng/dL per laboratory reference range
Testosterone < 50 ng/dL
Serum testosterone > 150 ng/dL at study entry
Patients must have a serum testosterone of 150 ng/dL or greater
Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
Evidence of castration resistance defined as disease progression despite a testosterone level < 50 ng/dL (or surgical castration)
Total testosterone < 50 ng/ml, except in patients with prior orchiectomy, where testosterone does not need to be measured; patients must continue their LHRH agonist therapy throughout study duration
Serum testosterone at screening < 50 ng/dL
Serum testosterone >= 240 ng/dL determined within 2 months prior to enrollment
Prior orchiectomy or serum testosterone levels <50 ng/dL determined within 4 weeks prior to start of study drug.
Hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL or > 6 nmol/L at the time of enrollment within 4 weeks prior to randomization
Serum testosterone level < 50 ng/dL at Screening visit
Testosterone ? 1.73 nmol/L (? 50 ng/dL) at screening.
Serum testosterone levels < 50ng/ml
Serum testosterone level < 50 ng/dL
Testosterone < 50 ng/dL; patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy
Serum testosterone < 50 ng/dL determined within 4 weeks of first administration of study drug
Both measurements are greater than 150 ng/dL or 5.2 nmol/L;
Effective castration (serum testosterone levels ?0.5 ng/mL).
Serum testosterone (total) less than 25 ng/ml at time of enrollment
Serum testosterone level:\r\n* If no prior androgen deprivation therapy:\r\n** A single measurement greater than 150 ng/dL within 3 months of day 1 of protocol therapy\r\n* If prior androgen deprivation therapy (either in adjuvant or biochemical relapse setting):\r\n** The two most recent measurements of serum testosterone prior to day 1 of protocol therapy must fulfill the following criteria:\r\n*** Both measurements are greater than 150 ng/dL\r\n*** The two measurements are spaced at least 14 days apart\r\n*** Both must be measured within 3 months of day 1 of protocol therapy\r\n*** There must not be an increase of > 50 ng/dL between these two successive measurements
Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL will not be eligible
Serum testosterone <50 nanogram per deciliter (ng/dL) (1.7 nanomole per liter [nM/L])
Surgical or medical castration with testosterone less than 50 ng/dL
Serum testosterone levels < 50 ng/dL
Medical or surgical castration with testosterone less than 50 ng/dL
Eugonadal state (serum testosterone > 150 ng/dL)
Serum testosterone, measured by liquid chromatography (LC)–mass spectrometry (MS)/MS, < 300 ng/dL and/or calculated free testosterone < 60 pg/mL
Baseline hypogonadism as defined as a testosterone < 50 ng/dL
Serum total testosterone >= 150 ng/dL (5.2 nmol/L)
Hypogonadism or severe androgen deficiency as defined by screening serum testosterone < 200 ng/dL
Serum testosterone =< 50 ng/dL
Serum testosterone < 50 ng/dL determined within 4 weeks of first administration of study drug
Patients may be receiving continuous hormonal ablation with surgical or medical castration with baseline testosterone < 50 ng/dL
Patients must have testosterone levels >= 100 ng/dL
Ongoing androgen deprivation with serum testosterone < 50 ng/dL (< 1.7 nM)
Patients receiving testosterone supplementation
Testosterone levels ? 100 ng/dL