Status:
COMPLETED
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
Lead Sponsor:
ECOG-ACRIN Cancer Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Hormone-sensitive Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
OBJECTIVES: Primary * Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer. Secondary * Determine wheth...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 26 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT00309985
Start Date
September 26 2006
End Date
January 31 2025
Last Update
December 11 2025
Active Locations (343)
Enter a location and click search to find clinical trials sorted by distance.
1
Providence Cancer Center
Anchorage, Alaska, United States, 99508
2
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
3
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
4
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499