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A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate


Phase 3
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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 CenterHouston, Texas  77030-4009