Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Immune System Diseases

Prostatic Neoplasms

Neoplasm Metastasis

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Abiraterone Acetate

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 Enzyme Inhibitors

YONSA® (abiraterone acetate), YONSA® 500 mg (four 125 mg tablets) or 625 mg (five 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].

Abiraterone acetate

Apalutamide, 240 mg (four 60 mg tablets) administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].

Apalutamide

Enzalutamide, 160 mg (four 40 mg capsules) administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].

Enzalutamide

Tito Fojo, MD, PhD

Ta-Chueh Rosenberg

The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent, uniform across the US and indifferent to race. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.

But with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.

Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.

A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer

Primary Objectives

1. In Veterans with castrate-sensitive prostate cancer demonstrate that administration of YONSA® (abiraterone acetate) first is not inferior to the administration of physician's choice enzalutamide or apalutamide first with efficacy measured by the rate (g) of tumor growth based on PSA measurement.
2. In Veterans with castrate-sensitive prostate cancer demonstrate that the efficacy of abiraterone acetate is superior in African American compared to Caucasian Veterans with efficacy measured by the rate (g) of tumor growth based on PSA determination.

PSA response based Prostate Cancer Working Group 2 guidelines.

James J. Peters Veterans Affairs Medical Center

Oncologist

Androgens

Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions

Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions

pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx

Cyberknife boost 18 Gy

pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx

Cyberknife boost 21 Gy

Young Seok Kim, M.D., Ph.D.

For the treatment for intermediate- and high-risk prostate cancer, Cyberknife boost will be used after 4 weeks of intensity modulated radiotherapy to pelvis. The boost doses are 18 Gy and 21 Gy in 3 fractions, respectively. The investigators plan to evaluate the toxicity of two dose groups and decide the appropriate dose for Cyberknife boost. Also, PSA control will be evaluated.

Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer

Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer

CTCAE v4.03, overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS)

PSA nadir + 2.0ng/ml or Start of salvage hormonal therapy

Late Effects of Normal Tissues (LENT) scoring system

Asan Medical Center

Associate professor

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.

Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.

The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).

Cultural CBSM

The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.

Standard CBSM

Frank Penedo, Ph.D.

The purpose of this study is to look at the effects of a 10-week stress management in-person group program. The program will study emotions, stress, and stress management techniques (such as relaxation and coping techniques) on quality of life, distress, depression, and physical health in Spanish- speaking, Hispanic/Latino men diagnosed with Prostate Cancer (PC).

This 5-year study evaluates the effects of a 10-week group-based linguistically translated and culturally adapted cognitive-behavioral stress and self-management (C-CBSM) intervention on symptom burden and health related quality of life (HRQoL) in Hispanic men treated for localized prostate cancer (PC). About 80% PC cases are diagnosed as early disease and have a 5- and 10-year survival rate of almost 100% and 99%, respectively.1 Most patients receive active treatment (\~70%) leading to prolonged treatment-related side effects and dysfunction persisting well beyond primary treatment. Survival is offset by chronic side effects such as sexual and urinary dysfunction, pain and fatigue that can lead to poor psychosocial functioning, impaired intimacy and social functioning, and masculinity concerns. Hispanic PC survivors report lower physical and social functioning, poorer emotional well-being and greater sexual and urinary dysfunction, even after accounting for SES and disease severity. These sequelae can lead to elevated glucocorticoid release and inflammatory cytokines that have a direct effect on these symptoms and can interfere with physiological pathways necessary for recovery of sexual and urinary functioning. We have shown that CBSM reduces symptom burden and improves HRQoL in bilingual Hispanic PC survivors. In a pilot we showed that a linguistic translation of CBSM with attention to sociocultural processes improved symptom burden and HRQoL in Spanish monolingual PC survivors. We have also shown that CBSM is associated with reduced glucocorticoid resistance and inflammatory gene expression pathways in circulating leukocytes among breast cancer survivors. We propose to (a) deliver a culturally adapted C-CBSM intervention in Spanish that places greater emphasis on salient sociocultural determinants of symptom burden and HRQoL in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo), (b) incorporate a neuroimmune model of symptom regulation and management, and (c) test the efficacy of C-CBSM, relative to standard non-culturally adapted CBSM, in two diverse Hispanic communities (Chicago \& Miami). We will test our aims in 200 Hispanic men post-treatment for localized PC with elevated symptom burden in a 2 x 4 randomized design with condition (C-CSBM vs. CBSM) as the between groups factors, and time (baseline, post-intervention \& 6- and 12-months post intervention) as the within groups factor.

Our Primary Aim is to determine whether randomization to C-CBSM, relative to standard CBSM, is associated with reduced symptom burden and improved HRQoL. Our Secondary Aims evaluate whether C-CBSM leads to greater improvements in the intervention targets (e.g., stress management, psychological distress \& interpersonal disruption), and physiologic adaptation (i.e., glucocorticoid receptor sensitivity \& inflammatory gene expression). We will also evaluate psychosocial and physiological mechanisms as mediators of C-CBSM's effects on our primary outcomes. We also explore several moderators (e.g., SES, acculturation, treatment, Hispanic origin) of C-CBSM's effect on primary outcomes and the effects of C-CBSM on cardiometabolic health (e.g., lipids, fasting glucose) via reduced inflammation.

Primary Aim 1: Determine whether participation in C-CBSM is associated with significantly greater reductions in symptom burden and improvements in HRQoL relative to participation in CBSM.

Secondary Aims:

Aim 2: Determine whether participation in C-CBSM is associated with significantly greater improvements in intervention targets (i.e., improved stress management, and reduced psychological distress and interpersonal disruption) relative to participation in the CBSM condition.

Aim 3: Determine whether participation in C-CBSM is associated with significantly greater activation of leukocyte glucocorticoid receptor and less inflammatory gene expression profiles relative to CBSM.

Aim 4: Determine whether C-CBSM related improvements in symptom burden and HRQoL are mediated by improvements in intervention targets and gene expression profiles.

Health Gatherings - For Your Health After Cancer

Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer

Symptom Burden will be measured using the Expanded Prostate Cancer Index Composite (EPIC) - Short Form Summary (EPIC-S). The EPIC-S is a 6-item questionnaire with a total score ranging from 6 - 29 with the lower score indicating greater symptom burden.

HRQoL will be measured using Functional Assessment of Cancer Therapy - Prostate (FACT-P) including 4 domains of the FACT-General (FACT-G). The questionnaire has 39 items, with the total score ranging from 0-156. Higher scores indicate better function.

Symptom Burden will be measured using the EPIC-Short Form Urinary Domain (EPIC-UIN). The EPIC-UIN is a 5-item questionnaire with a total score ranging from 9-43 with the higher score indicating greater symptom burden.

HRQoL will be measured using Patient-Reported Outcome Measurement Information System (PROMIS) short form for Fatigue Questionnaire. The total score ranges from 95-475 with the higher score indicating increased fatigue.

HRQoL will be measured using PROMIS short form for Pain Questionnaire. The items are item banks and the scoring via a computer adaptive testes (CAT) which use item response theory (IRT) to calculate a score that is transformed to a T score. Items are administered in an iterative approach where subsequent items are calibrated on prior ones. Once standard error reaches 2 or less, the CAT stops administering items. The higher the score the greater pain symptom.

Stress management skills will be measured using the Measure of Current Status Part A (MOCS-A) Questionnaire. MOCS-A is a 13-item questionnaire with a total score ranging from 0 - 52 with the higher score indicating greater stress management skills.

Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC sections I-II is a 14-item questionnaire with a total score ranging from 0-42 with the higher score indicating increased distress.

Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC section III is a 4-item questionnaire with a total score ranging from 0-12 with the lower score indicating increased distress.

PROMIS-Depression is a 28-item questionnaire with a total score ranging from 28-140 with the higher score indicating increased symptoms of depression.

PROMIS-Anxiety is a 29-item questionnaire with a total score ranging from 29-145 with the higher score indicating increased symptoms of anxiety.

Sickness Impact Profile (SIP) is a 20-item questionnaire responded with a yes or no. The total number of yes responses will be scored as 1 point with the total score ranging from 0-20 with the higher score indicating poor interpersonal function.

Leukocyte glucocorticoid receptor expression will be evaluated via blood serum

Inflammatory gene expression will be evaluated via blood serum.

Northwestern University

National Cancer Institute (NCI)

University of Miami

Professor

Prednisone

Trebananib

Glucocorticoids

Antineoplastic Agents, Hormonal

Angiogenesis Inhibitors

Growth Inhibitors

Abiraterone and prednisone will be given with maximum tolerated dose (MTD) of Trebananib (AMG)

Dose escalation phase to determine MTD of AMG

AMG 386 dose will be calculated using the subjects actual body weight (Kg). Supplied in 240 mg v will be administered as an intravenous (IV) infusion using an intravenous infusion pump given over a 60-minute period.

AMG 386

A 1,000 mg dose of abiraterone should be taken orally once daily

Abiraterone

Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference.

Ravi A Madan, M.D.

Background:

* Advanced prostate cancer is treated with surgery or drugs that lower the levels of androgens (male hormones) in the body. However, some cancers become resistant to this treatment. These types of cancers are known as castration-resistant prostate cancers.
* Interfering with the growth of blood vessels that feed tumors can slow prostate cancer growth. Trebananib (AMG 386), a new anticancer drug, targets the blood vessels that feed tumors. It has been tested for different types of cancer, but not for prostate cancer. Researchers want to see if AMG 386 can slow disease progression in men with castration-resistant prostate cancer. AMG 386 will be given with abiraterone and prednisone, two drugs that are also used to treat advanced prostate cancer.

Objectives:

- To test the safety and effectiveness of AMG 386 with abiraterone for castration-resistant prostate cancer.

Eligibility:

- Men at least 18 years of age with castration-resistant prostate cancer.

Design:

* Participants will be screened with a physical exam, medical history, and imaging studies. Blood and urine samples will also be collected.
* Participants will be separated into two groups.
* The first group will have AMG 386 once per week for a total of four doses during a 28-day cycle. They will also take abiraterone once a day and prednisone twice a day, every day of the cycle.
* The second group will not have AMG 386. They will take abiraterone once a day and prednisone twice a day, every day of the 28-day cycle.
* Treatment will be monitored with frequent blood tests and imaging studies.
* Participants will continue to take the study drugs as long as the disease does not progress and there are no severe side effects.

Background:

* Inhibition of angiogenesis, either as a stand-alone approach or in combination with chemotherapy, has demonstrable antitumor efficacy against castration-resistant prostate cancer (CRPC) and there are several antiangiogenic agents that are now in clinical trials in this population of patients.
* AMG 386 is a novel peptide-Fc fusion protein. The molecule is a non-glycosylated homodimer engineered by fusing an Immunoglobulin gamma-1 heavy chain constant region, partial (IgG1 Fc) domain to 4 copies of an anti-angiopoietin 2 (Ang2) peptide. AMG 386 sequesters Ang1 and Ang2, thereby preventing their interaction with Tie2 and inhibiting tumor endothelial cell (EC) proliferation and tumor growth.
* Abiraterone acetate is a small molecule that irreversibly inhibits Cytochrome P450 17A1 (CYP17), a rate-limiting enzyme in androgen biosynthesis, to block residual androgen synthesis in the adrenal gland and tumor cells.
* Previous studies have demonstrated that in vivo alterations of testosterone levels regulate the expression of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and angiopoietin family members. Dual targeting of the androgen and angiogenic axis represents a novel approach as a potential targeted therapy for patients with metastatic castration-resistant prostate cancer (CRPC).

Objectives:

-To estimate the treatment effect as measured by progression free survival (PFS) in patients treated with AMG 386 plus abiraterone/prednisone relative to abiraterone/prednisone alone.

Eligibility:

-Patients with progressive, metastatic CRPC with radiographic evidence of progression after primary therapy (surgery or radiotherapy) and adequate androgen deprivation therapy.

Design:

* This is an open-label, randomized, phase II multicenter trial with a two-part design and a planned accrual of 88 patients.
* An initial run-in phase of AMG 386 will be conducted with 15mg/kg weekly escalating to 30mg/kg weekly to establish the MTD. The decision on declaration of a safe and tolerable dose during this run-in phase will lead to the second part of the study consisting of a randomized comparison of abiraterone/prednisone plus AMG 386 (at the established maximum tolerated dose (MTD)) vs. abiraterone/prednisone alone.
* AMG 386 will be administered intravenously every week, on days 1, 8, 15 and 22 of each 28-day cycle. Abiraterone acetate will be self-administered once daily by mouth and prednisone will be self-administered by mouth either twice per day at 5 mg per dose or once per day at 10 mg per dose as the patient prefers.

AMG 386 and Abiraterone for Advanced Prostate Cancer

A Phase II Multicenter Study of AMG 386 and Abiraterone in Metastatic Castration Resistant Prostate Cancer

The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity was less than 33%.

DLTs are defined as any grade 3 or higher hematologic (excluding anemia) or non-hematologic toxicity considered to be possible related to AMG 386. Any treatment related adverse events that lead tor reduction of dose exposure of either agent (duration or dose) by \>50% in cycle 1 will be considered a DLT.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Clinical progression is assessed by the Response Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Radiographic progression free survival is defined as the duration of time from start of treatment to time of radiographic progression by computed tomography (CT) scan (or magnetic resonance imaging (MRI)) or bone scan. Progression is a minimum of two new lesions observed on bone scan. The minimum size for a measurable lesion on CY and MRI should be twice the slice thickness based on the assumption that CT slice thickness is 500 or less.

Overall Survival is the time between the first day of treatment to the day of death.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Principal Investigator

Dose escalation phase to determine MTD of AMG

AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).

Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily

DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg

The randomized portion is 30 mg/kg.

DL 1 Run in - 15mg/kg

DL 2 Run in - 30mg/kg

Abiraterone and prednisone will be given with maximum tolerated dose (MTD) of Trebananib (AMG)

AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg). Supplied in 240 mg v will be administered as an intravenous (IV) infusion using an intravenous infusion pump given over a 60-minute period.

Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily

Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference.

Abiraterone, Prednisone and AMG

Abiraterone and prednisone only

Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily

Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference.

Abiraterone and Prednisone Only

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Not meeting definition for Hispanic or Latino

Mexican, Puerto Rican, Cuban, Central or So Amer.

Black or African American

White

Unknown

Race/Ethnicity, Customized

United States

Region of Enrollment

>4.0 mg/mL

<4.0 mg/mL

Prostatic Specific Antigen (PSA) reference range is 4.0 ng/mL

OnStudy Prostatic Specific Antigen (PSA)

Dr. Ravi Madan

Dose escalation phase to determine MTD of AMG AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).

Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg The randomized portion is 30 mg/kg.

One patient of the 9 (i.e., Run-in in Participant Flow) was not evaluable for responses as we previously defined through the document. Thus, it cannot be included in the PFS assessment. Patient came off the trial early for other reasons.

Progression Free Survival (PFS)

Radiographic Progression Free Survival

Overall Survival

Count of Participants With Serious and Non-serious Adverse Events

All participants who had at least one dose of Abiraterone, prednisone, and/or Trebananib (AMG 386).

All Participants

Maximum Tolerated Dose (MTD)

Per protocol, only participants in the Run-in phase were evaluated for DLT.

Dose Limiting Toxicity (DLT)

Overall Study

Carcinoma

Reproductive Control Agents

Androgen Antagonists

Cyproterone Acetate

Cyproterone

Buserelin

Prolactin Release-Inhibiting Factors

Immediate Endocrine Therapy. Orchiectomy or LHRH Agonist Therapy plus (initially) Antiandrogen Therapy. Buserelin (BSRL); Cyproterone acetate (Androcur) (CPTR), Cyproterone acetate (Androcur)(NSC-81430). Treatment initiated within 1 month of randomization.

Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms.

Immediate Orchiectomy or depot LHRH

Delayed Orchiectomy or depot LHRH

Urs Studer, MD

Objectives

I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy).

II. Compare the overall survival of these two groups of patients.

III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups.

IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy.

V. Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.

Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer

Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients With Nonmetastatic Asymptomatic Carcinoma of the Prostate

prostate cancer mortality and overall mortality according to pretreatment laboratory data

prostate cancer mortality and overall mortality according to particular sub-groups (following stratification factors): performance status (0 vs 1), the local tumor extent (T0-2 vs T3-4), nodal status (N0 vs N1-2), the choice of hormonal therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.	NCT05422911	Metastatic Canc... Neoplasm, Prost...	Abiraterone ace... Apalutamide Enzalutamide	-	James J. Peters Veterans Affairs Medical Center
Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer	NCT03322020	Neoplasm, Prost...	Cyberknife boos... Cyberknife boos...	20 Years -	Asan Medical Center
Health Gatherings - For Your Health After Cancer	NCT03344757	Prostate Neopla... Genital Neoplas... Urogenital Neop... Neoplasm, Prost... Genital Disease... Prostatic Disea...	Cultural CBSM Standard CBSM	18 Years -	University of Miami
AMG 386 and Abiraterone for Advanced Prostate Cancer	NCT01553188	Prostatic Neopl... Prostate Cancer Neoplasm, Prost... Neoplasm,Prosta...	AMG 386 Abiraterone Prednisone	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer	NCT01819285	Neoplasm, Prost...	Immediate Orchi... Delayed Orchiec...	- 80 Years	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for neoplasm, prostate