Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Schiffler Cancer Center
• Collaborators: Kent E. Wallner, M.D.; Sylvester, John, M.D.
• Treatments: Bicalutamide; Hormones

Criteria

Inclusion Criteria:

• High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ).

• CT of the abdomen and pelvis and bone scan without evidence of metastases.

• An enzymatic prostatic acid phosphatase must be obtained prior to randomization.

• A serum testosterone must be obtained prior to initiation of androgen deprivation therapy.

• No prior pelvic external beam radiation therapy for prostate cancer or other malignancies.

• No prior androgen deprivation therapy.

• Minimum 5 year life expectancy.

• No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.

Exclusion Criteria:

• Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.