Status:
TERMINATED
FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 hi...
Detailed 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 hor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01439542
Start Date
September 1 2011
End Date
November 1 2017
Last Update
August 9 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6