FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity
Outcome Description:
Assessment of late genitourinary and gastrointestinal toxicity at 1 year as assessed by the Common Toxicity Criteria
Outcome Time Frame:
year 1 of follow-up
Safety Issue:
Yes
Principal Investigator
Glenn Bauman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
London Regional Cancer Program of the Lawson Health Research Institute
Authority:
Canada: Ethics Review Committee
Study ID:
R-11-220
NCT ID:
NCT01439542
Start Date:
September 2011
Completion Date:
Related Keywords:
- Prostate Cancer
- High risk prostate cancer
- Prostatic Neoplasms
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