Testosterone >  ng/dL within  days prior to Step  registration
Serum testosterone concentration ? ng/dL sustained by medical or surgical castration Parts A,B or D (TNBC)
Serum testosterone concentration ? ng/dL sustained by medical or surgical castration.
Serum testosterone < ng/dL
Currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin), oxymetholone, danazol, fluoxymesterone (Halotestin), or testosterone-like agents.
Serum testosterone level <  ng/mL
Serum testosterone ?  ng/dL
Testosterone level =<  ng/dL
Serum testosterone <  ng/ml
Screening serum testosterone >  ng/dL
Be surgically or medically castrated, with serum testosterone levels of ?  ng/dL (. nM)
Testosterone level <  ng/dL
Patient may have had prior neoadjuvant and/or adjuvant therapy (chemotherapy, vaccines or experimental agents) within  weeks prior to randomization, if the PSA rise and PSADT were documented after the testosterone level was >  ng/dL
Patient must have hormone-sensitive prostate cancer as evident by a serum total testosterone level >  ng/dL within  weeks prior to randomization
Serum testosterone level <  ng/dL at screening
Testosterone =<  ng/dL
Not a candidate for standard effective therapy NOTE: In men with prostate cancer, baseline testosterone levels must also be ?ng/dL (? .nM) and surgical or ongoing medical castration must be maintained throughout the duration of the study.
Serum testosterone of  ng/dL or greater (if initial T is <  it can be repeated [recommended before  AM] and if >  patient will be considered eligible). If patient was on testosterone supplementation, testosterone measurements need to be obtained >  weeks off supplements
Serum testosterone >  ng/mL
Serum testosterone level =<  ng/dL at the screening visit
Baseline testosterone >=  ng/dl
Testosterone level ?  ng/dL
Asymptomatic or symptomatic hormone naive men with testosterone levels >=  ng/dL with previously treated localized prostate cancer who now have rising PSAs and five or fewer bone metastases
Men with baseline serum testosterone <  ng/dL
Serum testosterone >  ng/dL. For patients treated up to  month of LHRH agonist, a testosterone measurement prior to the LHRH treatment will be used to determine eligibility, and must have been >  ng/dL. If no testosterone level is available from before LHRHa injection up to  days prior to study entry, the patient will be ineligible.
Surgically or ongoing medically castrated, with baseline testosterone levels of =<  ng/dL =< . nM).
Eugonadal state (serum testosterone >  ng/dL).
Serum testosterone >=  ng/dl
Baseline testosterone >  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 >=  ng/dL
Serum testosterone >=  ng/dL
Surgically or ongoing medically castrated, with baseline testosterone levels of =<  ng/dL (=< . nM)
Requires estrogen or testosterone
Ongoing androgen deprivation with serum testosterone <  ng/dl
Patients may be receiving continuous hormonal ablation with surgical or medical castration with baseline testosterone < ng/dL
Serum testosterone >=  ng/dL
Bilirubin < . ng/dl
Creatinine < . ng/dl
Serum testosterone levels <  ng/L after surgical or continued chemical castration
Patients must have ongoing therapy to maintain serum testosterone <  ng/dL
Androgens (testosterone, dihydroepiandrosterone, etc.);
Known castrate-resistant disease with serum testosterone level less than or equal to (</=)  nanograms per deciliter (ng/dL) with prior surgical castration or ongoing androgen deprivation for the duration of the study
Known serum testosterone =<  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  ng/dl can be used to exclude hypogonadism
Specific eligibility criteria for Part  CRPC expansion cohort: Ongoing androgen deprivation therapy with a serum testosterone level <. nanomoles/L or < ng/dL.
Patients must have a serum testosterone <  ng/dL demonstrated within  month of study entry
Be surgically or medically castrated, with serum testosterone levels of ?  ng/dL (. nM)
Testosterone or testosterone-like agents (methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, dehydroepiandrosterone, androstenedione) other androgenic compounds or anti-androgens within  days prior to day  of protocol therapy
Testosterone >=  ng/dL
Baseline testosterone >=  ng/dl
Serum testosterone levels less than (<)  nanogram per deciliter (ng/dL) determined within  weeks prior to start of study drug
Patients must have a serum total testosterone level >=  ng/dL at the time of enrollment within  weeks prior to randomization
Hypogonadism or severe androgen deficiency as defined by screening serum testosterone <  ng/dL
Surgically or medically castrated, with testosterone levels of less than (<)  nanogram per deciliter (ng/dL)
Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than  ng/dL below the normal range for the institution
Participants must have a testosterone level <  ng/dL
Participants must have a testosterone levels <  ng/dL
Testosterone >=  ng/dL per laboratory reference range
Testosterone <  ng/dL
Serum testosterone >  ng/dL at study entry
Patients must have a serum testosterone of  ng/dL or greater
Ongoing androgen blockade demonstrated by serum testosterone concentration of less than  ng/dL
Total testosterone <  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 <  ng/dL
Serum testosterone >=  ng/dL determined within  months prior to enrollment
Prior orchiectomy or serum testosterone levels < ng/dL determined within  weeks prior to start of study drug.
Serum testosterone level <  ng/dL at Screening visit
Serum testosterone levels < ng/ml
Serum testosterone level <  ng/dL
Castrate levels of serum testosterone (=<  ng/dL or . mmol/L) confirmed within two weeks prior to day  of treatment; testosterone levels will not be required for patients who have had bilateral orchiectomy
Testosterone <  ng/dL; patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy
Serum testosterone <  ng/dL determined within  weeks of first administration of study drug
Effective castration (serum testosterone levels ?. ng/mL).
Serum testosterone (total) less than  ng/ml at time of enrollment
Patients with pure small cell neuroendocrine carcinoma on histology are not required to have received prior androgen deprivation therapy (ADT) or castrate levels of testosterone, but their testosterone state should be maintained for the duration of the study. Other patients are required to have surgical or ongoing chemical castration, with baseline testosterone level <ng/dL.
Serum testosterone level:\r\n* If no prior androgen deprivation therapy:\r\n** A single measurement greater than  ng/dL within  months of day  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  of protocol therapy must fulfill the following criteria:\r\n*** Both measurements are greater than  ng/dL\r\n*** The two measurements are spaced at least  days apart\r\n*** Both must be measured within  months of day  of protocol therapy\r\n*** There must not be an increase of >  ng/dL between these two successive measurements
Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than  ng/dL will not be eligible
Serum testosterone < nanogram per deciliter (ng/dL) (. nanomole per liter [nM/L])
Surgical or medical castration with testosterone less than  ng/dL
Serum testosterone levels <  ng/dL
Medical or surgical castration with testosterone less than  ng/dL
Eugonadal state (serum testosterone >  ng/dL)
Serum testosterone, measured by liquid chromatography (LC)mass spectrometry (MS)/MS, <  ng/dL and/or calculated free testosterone <  pg/mL
Baseline hypogonadism as defined as a testosterone <  ng/dL
Hypogonadism or severe androgen deficiency as defined by screening serum testosterone <  ng/dL
Serum testosterone =<  ng/dL
Serum testosterone <  ng/dL determined within  weeks of first administration of study drug
Patients may be receiving continuous hormonal ablation with surgical or medical castration with baseline testosterone <  ng/dL
Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of <  ng/dL)
SUB-STUDY III: Castrate-levels of testosterone (total testosterone <  ng/dL)
Patients must have testosterone levels >=  ng/dL
Ongoing androgen deprivation with serum testosterone <  ng/dL (< . nM)
Patients receiving testosterone supplementation
Testosterone levels ?  ng/dL
Must continue ongoing androgen deprivation therapy with castrate levels of serum testosterone < nanogram/deciliter (ng/dL)