Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer

Completed · Phase 3

Conditions studied: Metastatic Hormone-sensitive Prostate Cancer

In brief

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer. PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.

Key facts

Study ID

NCT00309985

Run by

ECOG-ACRIN Cancer Research Group

People needed

790

Starts

2006-09-26

Expected to finish

2025-01-31

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed prostate cancer
• Metastatic disease
• On androgen-deprivation therapy for < 120 days
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• PS 2 eligible only if decline in PS is due to metastatic prostate cancer
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ upper limit of normal (ULN)
• Alanine aminotransferase (ALT) ≤ 2.5 times ULN
• Creatinine clearance ≥ 30 mL/min
• Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
• Partial thromboplastin time (PTT) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
• Fertile patients must use effective contraception
• At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization
• Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true:
• Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as defined by 1 of the following:
• PSA < 0.1 ng/dL after prostatectomy plus hormonal therapy
• PSA < 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy
• Therapy lasted no more than 24 months
• Last depot injection must have expired by the 24-month mark
• Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation
• Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial castration to prevent flare
• More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial
• Concurrent participation in nontherapeutic trials allowed
• Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy

You may not qualify if…

• Prostate-specific antigen (PSA) level has risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization
• Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin
• Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair
• Peripheral neuropathy > grade 1
• History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• Active cardiac disease, including the following:
• Active angina
• Symptomatic congestive heart failure
• Myocardial infarction within the past 6 months
• Prior chemotherapy in adjuvant or neoadjuvant setting
• Prior hormone therapy in the metastatic setting
• Concurrent 5-alpha reductase inhibitors
• Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202

Where it is running

• Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Hembree Mercy Cancer Center at St. Edward Mercy Medical Center — Fort Smith, Arkansas, United States
• Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Alta Bates Summit Comprehensive Cancer Center — Berkeley, California, United States
• Peninsula Medical Center — Burlingame, California, United States
• California Cancer Care, Incorporated - Greenbrae — Greenbrae, California, United States
• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• Tibotec Therapeutics - Division of Ortho Biotech Products, LP — Marysville, California, United States
• Mather Veteran Affairs Medical Center — Mather, California, United States
• Mercy Cancer Center at Mercy Medical Center — Merced, California, United States
• Memorial Medical Center — Modesto, California, United States
• Sutter Health - Western Division Cancer Research Group — Novato, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• California Pacific Medical Center - California Campus — San Francisco, California, United States
• Sutter Pacific Medical Foundation — Santa Rosa, California, United States
• Saint Helena Hospital — St. Helena, California, United States
• Tahoe Forest Cancer Center — Truckee, California, United States
• Sutter Solano Medical Center — Vallejo, California, United States
• University of Colorado Cancer Center at UC Health Sciences Center — Aurora, Colorado, United States
• Veterans Affairs Medical Center - Denver — Denver, Colorado, United States
• Shaw Regional Cancer Center — Edwards, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Providence Cancer Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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