Stereotactic body radiation therapy: localized radiation therapy
Study summary
This study will be undertaken to evaluate the feasibility of replacing systemic Androgen Deprivation Therapy (ADT) with targeted local delivery of an anti-androgen agent alone in patients in whom ADT + radiation therapy is indicated for the treatment of localized prostate cancer.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with biopsy proven localized prostate cancer in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer)
* Patients must have at least 1 MRI detected; biopsy proven prostate cancer.
* Patients diagnosed as one of the following:
1. National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer, OR
2. NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR
3. NCCN high risk prostate cancer due to Prostate Specific Antigen (PSA) \> 20 AND refuses to receive systemic ADT.
* Age \>18 years.
Exclusion Criteria:
* NCCN high risk patients eligible for treatment with systemic ADT who do not refuse systemic ADT.
* Patients receiving prior radiotherapy or surgery for prostate cancer.
* Patients receiving prior or ongoing ADT.
* Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
* Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of \> 3 months.
* Prostate volume more than 80 cc at prior MRI imaging.
* International Prostate Symptom Score ≥ 20.
Primary outcome measure(s)
Feasibility of replacing systemic androgen tx with targeted local delivery — 27 months Ability to successfully implant the prostate with Biolen and a lack of implant toxicity that interferes with the capacity to complete intended radiation therapy.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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