Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002855
• Date of registration: 01/11/1999
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
• Scientific title: A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate
• Date of first enrolment: August 1996
• Target sample size: 306
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002855
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Randall E. Millikan, MD, PhD
• Affiliation: M.D. Anderson Cancer Center

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: Bicalutamide

Drug: Doxorubicin hydrochloride

Drug: Estramustine Phosphate Sodium

Drug: Flutamide

Drug: Ketoconazole

Drug: Nilutamide

Drug: Therapeutic Hydrocortisone

Drug: Vinblastine

Procedure: Conventional Surgery

Primary Outcome(s)

Time to Progression [Time Frame: From baseline to post treatment (minimally 24+ weeks)]

Secondary ID(s)

CDR0000065105

DM95-231

MDA-DM-95231

NCI-G96-1044

P30CA016672

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)