FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer

• Status: Terminated
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to examine the safety of a shorter course of radiation treatments combined with one year of androgen deprivation therapy. The study will test this treatment in men with high risk prostate cancer who have significant other illnesses or circumstances such that conventional long term radiotherapy and hormone therapy is not recommended by their physician or desired by the patient.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Androgens; Hormones; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• High risk prostate cancer:

• clinical stage T3 (cT3) prostate cancer or

• pre-treatment PSA > 20 or

• Gleason score>8 on Trans-Rectal Ultrasound (TRUS) biopsy

• Score of > 3 on the Vulnerable Elderly Scale or refuses standard radiotherapy + androgen deprivation therapy

• No evidence of extra-prostatic disease on screening bone scan and Computed Tomography (CT) scan (non-contrast CT used for CT simulation acceptable)

• Signed written and voluntary informed consent provided.

• Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

• Age ≥ 18 years

Exclusion Criteria:

• Patients not meeting the eligibility criteria

• Prior pelvic radiotherapy or brachytherapy

• Use of anti-coagulation (low molecular weight heparin or Coumadin)

• History of inflammatory bowel disease, Crohn's disease, diverticulitis or collagen vascular disease (other than rheumatoid arthritis)

• Previous treatment for malignancy (other than basal or squamous cell skin cancer) within 3 years of prostate cancer diagnosis