A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 21
- Locations
- 78
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.
Detailed Description
OBJECTIVES:
Primary
- Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy.
Secondary
- Compare biochemical control in patients treated with these regimens.
- Determine the toxicity of these regimens in these patients.
- Compare the time to clinical failure, as measured by progression on bone scan or CT scan or a prostate-specific antigen (PSA) doubling time of ≤ 32 weeks, in patients treated with these regimens.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Intervention: flutamide (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Intervention: vinblastine sulfate (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Intervention: flutamide (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Intervention: bicalutamide (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Intervention: docetaxel (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Intervention: doxorubicin hydrochloride (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Intervention: estramustine phosphate sodium (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Intervention: ketoconazole (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Intervention: paclitaxel (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Intervention: releasing hormone agonist therapy (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Intervention: bicalutamide (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Intervention: docetaxel (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Intervention: doxorubicin hydrochloride (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Intervention: estramustine phosphate sodium (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Intervention: ketoconazole (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Intervention: paclitaxel (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Intervention: releasing hormone agonist therapy (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Intervention: vinblastine sulfate (Drug)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: From date of randomization to the date of death due to any cause
Secondary Outcomes
- Time to Clinical Failure(Time from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time ≤ 32 weeks)
- Biochemical control(From date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks)
- Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities(From the beginning of treatment to 90 days post treatment)