Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

• Status: Terminated
• Trial end date: 2017-03-20
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: AstraZeneca; Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
• Treatments: Bicalutamide; Flutamide; Goserelin; Leuprolide

Criteria

Inclusion Criteria:

1. Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging

2. Radical prostatectomy and bilateral lymph node dissection performed

3. Pathologic assessment of surgical specimens by MDACC pathologist

4. High risk of clinical or biochemical failure post prostatectomy (must fulfill one of the following criteria): pathology; a) Gleason grade sum score greater than or equal to 8, b) Seminal vesicle involvement, c) Extraprostatic extension with positive surgical margins and Gleason greater than or equal to 7

5. Radical prostatectomy performed within 90 days of enrollment and serum PSA level < 0.1ng/ml

6. Written informed consent

Exclusion Criteria:

1. Any evidence of metastatic disease confirmed prior to enrollment

2. Inability to confirm pathologic risk factors or inadequate prostatectomy (see item 4.1.5).

3. Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer

4. Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to enrollment in study

5. Elevation of liver function tests 2x normal

6. Contraindication to the use of LH-RH agonists or antiandrogens

7. Active secondary malignancy (other than squamous or basal cell skin cancer) within five years prior to enrollment in study

8. Any concomitant medical condition that would make it undesirable for the 7patient to participate in the trial or jeopardize compliance with the protocol