A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate
N/A
N/A
Male
Prostate Cancer
Trial Information
A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate
OBJECTIVES:
- Determine the clinical benefit, as measured by time to progression and overall
survival, of chemo/hormonal therapy compared to androgen ablation alone, when given as
the initial systemic treatment in patients with acinar adenocarcinoma of the prostate
that is not amenable to local therapy.
- Validate the clinical significance of PSA criteria for progression.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients are treated with medical or surgical castration followed by an
anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
- Arm II: Patients receive chemo/hormonal therapy for 3 eight week courses, followed by
total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with
doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks of rest.
These patients are also maintained on hydrocortisone both during treatment and during
rest.
Patients in arm II have a long-term central venous access device inserted.
PROJECTED ACCRUAL: A total of 368 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven acinar adenocarcinoma of the prostate
- Metastatic or locally advanced disease that either is not appropriately treated with
surgery or radiation, or has recurred following previous "definitive" local therapy
- No CNS metastases
- No histologic subtypes, such as pure ductal or any component of small cell carcinoma
- Elevated PSA (at least 1.0 ng/mL in patients with prior prostatectomy or 4.0 ng/mL in
those with prostate in place)
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- At least 3 years
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Conjugated bilirubin no greater than 0.8 mg/dL or total bilirubin no greater than 1.5
mg/dL
- Transaminase no greater than 4 times upper limit of normal
Renal:
- Creatinine clearance at least 40 mL/min
Cardiovascular:
- No evidence of bifascicular block on EKG
- No evidence of active ischemia on EKG
- No prior history of transient ischemic attack
- No evidence of congestive heart failure
Other:
- No active peptic ulcer disease
- No regular use of antacid or H2 blockers
- No known or predicted achlorhydria
- No concurrent use of terfenadine, astemizole, omeprazole, or cisapride
- No second malignancy unless curatively treated
- No history of deep venous thrombosis
- No history of pulmonary embolism
- No serious co-morbidity
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior cytotoxic systemic therapy
Endocrine therapy:
- Prior androgen deprivation therapy allowed if given for no more than 6 months to
downstage primary
- No androgen deprivation therapy within 1 year prior to study
Radiotherapy:
- No prior cytotoxic systemic therapy (including systemic strontium-89 irradiation)
- Prior definitive radiotherapy to the prostate and/or one metastatic site allowed
- At least 8 weeks since radiotherapy to the pelvis
- At least 3 weeks since radiotherapy to a single metastatic site
Surgery:
- Prior prostatectomy allowed
Other:
- No concurrent anti-anginal therapy or aggressive anticoagulants
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to Progression
Outcome Time Frame:
From baseline to post treatment (minimally 24+ weeks)
Safety Issue:
No
Principal Investigator
Randall E. Millikan, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
DM95-231
NCT ID:
NCT00002855
Start Date:
August 1996
Completion Date:
June 2005
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage III prostate cancer
- stage IV prostate cancer
- recurrent prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
