RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy after surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of mitoxantrone given after surgery in treating patients who have prostate cancer that is at high risk for recurrence.

Condition	Treatment or Intervention	Phase
stage III prostate cancer stage II prostate cancer adenocarcinoma of the prostate stage IV prostate cancer stage I prostate cancer	Drug: mitoxantrone	Phase II

Further Study Details: 

OBJECTIVES: I. Assess the feasibility of enrolling patients with adenocarcinoma of the prostate at high risk for recurrence following radical prostatectomy in an adjuvant mitoxantrone trial.

II. Determine if this adjuvant therapy results in a delay in time to failure or a decrease in the number of treatment failures compared to historical controls in this patient population.

PROTOCOL OUTLINE: Patients receive mitoxantrone IV over 10-30 minutes every 21 days. Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for the first 3 years, and then every 6 months for the next 3 years or until disease progression.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study over 18 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Adenocarcinoma of the prostate treated by radical prostatectomy within the past 3 months
• Considered to be at high risk for recurrence as defined by at least 1 of the following characteristics on the radical prostatectomy specimen: Positive seminal vesicles; Gleason 6 and preoperative PSA greater than 18 ng/mL; Gleason 7 and preoperative PSA greater than 14 ng/mL; Gleason 8, 9, or 10 and any preoperative PSA
• Undetectable PSA (i.e., less than 0.1 ng/mL) within 3 months following radical prostatectomy and at time of enrollment
• Negative lymph nodes at time of radical prostatectomy if lymphadenectomy performed
• Extracapsular penetration and/or positive surgical margins allowed

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent filgrastim or sargramostim except for febrile neutropenia
• Chemotherapy: No other concurrent chemotherapy
• Endocrine therapy: No prior neoadjuvant or adjuvant hormonal therapy for prostate cancer; No concurrent hormonal therapy except for non-disease related conditions (e.g., insulin for diabetes); No concurrent systemic corticosteriods unless for adrenal insufficiency; No concurrent prednisone, dexamethasone, or other steroidal antiemetics; At least 6 months since prior finasteride; No concurrent finasteride; No concurrent antiandrogens (e.g., flutamide, bicalutamide, nilutamide) or gonadotropin releasing hormone agonists (e.g., leuprolide, goserelin)
• Radiotherapy: No prior adjuvant radiotherapy for prostate cancer; No prior pelvic radiotherapy for prostate cancer
• Surgery: See Disease Characteristics
• Other: At least 6 months since prior saw palmetto; No concurrent compounds with 5 alpha-reductase inhibitor activity (e.g., saw palmetto)

--Patient Characteristics--

• Age: 18 and over
• Performance status: Zubrod 0-1
• Life expectancy: Not specified
• Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 2 times ULN
• Renal: Not specified
• Cardiovascular: No New York Heart Association class III or IV cardiac disease or angina pectoris; No myocardial infarction within the past 6 months

Study chairs or principal investigators

Richard L. Schilsky,  Study Chair,  Cancer and Leukemia Group B   

Study ID Numbers:  CDR0000067021; CLB-99801
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003858
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08