Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will explore the combination of a stereotactic body radiation therapy (SBRT) approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for older men with high risk prostate cancer, or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy.

The purpose of this study is to examine the safety of a shorter course of radiation treatment combined wtih androgen deprivation therapy.

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

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Androgens; Ascorbic Acid; Estrogens, Conjugated (USP); Methyltestosterone

Criteria

Inclusion Criteria:

• High risk prostate cancer

• Has had multidisciplinary consultation with radiation oncologist and urologist

• Age >70 or refuses standard treatment

• No evidence of extra-prostatic disease on screening bone scan and 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

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

• patients on androgen deprivation therapy > 2 months prior to study enrolment