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

Lawson Health Research Institute

Status and phase

Terminated

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Luteinizing Hormone Releasing Hormone (LHRH) Agonist

Radiation: Stereotactic Body Radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT01439542

R-11-220

FASTR (Other Identifier)

Details and patient eligibility

About

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.

Full description

Randomized controlled trials have established the improved efficacy (better biochemical control and disease free survival) of combined radical radiation (70-80Gy/7-8 weeks) combined with long term hormone therapy (2-3 years of adjuvant luteinizing hormone releasing hormone (LHRH) agonist) compared to a primary hormone therapy or radiotherapy alone in men with locally advanced/high risk disease. While this approach may be tolerable in fit individuals, this combination may not be well tolerated by frail individuals or those who live at a distance who may find it difficult to attend for 7 weeks of radiation due to travel considerations. Those individuals with co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those conditions exacerbated by long term hormone therapy.

This pilot study will explore the combination of a stereotactic body radiotherapy (SBRT) approach (designed to be iso-effective for late effects for standard radiotherapy) combined with one year of LHRH agonist for older men with high risk disease who are less fit (Vulnerable Elderly Score > 3) or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy.

Enrollment

19 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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