- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02229734
Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2 (FASTR-2)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Randomized controlled trials have established the improved efficacy (better biochemical control and disease free survival) of combined radical radiation (70-80 Gy over 7-8 weeks) combined with long term hormone therapy (2-3 years of adjuvant LHRH agonist) compared to a primary hormone therapy or radiation therapy 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 treatments. Those individuals with co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those conditions exacerbated by long term hormone therapy.
The combination of short course radiation and hormone therapy was explored in the FASTR trial. As part of the trial, patients received 12 months of hormone therapy with radiation treatment to the pelvic lymph nodes (dose of 25 Gy in 5 fractions, 1 fraction per week) concomitant with radiation treatment to the prostate (dose of 40 Gy in 5 fractions, 1 fraction per week). The study was discontinued due to toxicity. For the FASTR-2 study, these concerns are being addressed through the use of a lower total dose to the prostate (35 Gy in 5 fractions, 1 fraction per week). Given the uncertainty of the benefit of pelvic nodal radiation in prostate cancer, it was decided to omit the pelvic nodal radiation in the FASTR-2 study. In addition, given the recent evidence supporting the equivalence of 18 months of hormone therapy, compared to 36 months, it was decided to lengthen the duration of hormone therapy in the FASTR-2 study to 18 months (versus 12 months in the FASTR study).
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program of the Lawson Health Research Institute
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiation plus Androgen Supression
Radiation plus Androgen Suppression give as stereotactic radiation 7gray (Gy) per week x 5 weeks and leuprolide 45mg every 6 months for 18 months
|
Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)
Leuprolide 45mg every 6 months for a total of 18 months
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genitourinary and Gastrointestinal Toxicity at 1 year
Time Frame: Year 1 of follow-up
|
Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria
|
Year 1 of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Free Survival at 3 years
Time Frame: 1, 2, and 3 years of follow-up
|
Defined by absence of clinical relapse and prostatic specific antigen (PSA) failure as per the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition
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1, 2, and 3 years of follow-up
|
Quality of Life
Time Frame: 1, 2, and 3 years of follow-up
|
Measured using the Prostate Cancer Radiotherapy questionnaire
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1, 2, and 3 years of follow-up
|
Genitourinary and Gastrointestinal Toxicity at 2 years
Time Frame: Year 2 of follow-up
|
Genitourinary and gastrointestinal toxicity measured at year 2 of follow-up using the Common Toxicity Criteria Safety Issue? (FDAAA) Yes |
Year 2 of follow-up
|
Genitourinary and gastrointestinal toxicity measured at 3 years
Time Frame: Year 3 of follow-up
|
Genitourinary and gastrointestinal toxicity measured at year 3 of follow-up using the Common Toxicity Criteria
|
Year 3 of follow-up
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FASTR-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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