Stereotactic Body Radiation Therapy for Recurrent Prostate Cancer
(DASBRT-RPC Trial)
Trial Summary
What is the purpose of this trial?
There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt to maintain control and minimize side effects.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Daily-adaptive Stereotactic Body Radiation Therapy for recurrent prostate cancer?
Is Stereotactic Body Radiation Therapy (SBRT) safe for treating prostate cancer?
Stereotactic Body Radiation Therapy (SBRT), also known as Stereotactic Ablative Radiotherapy (SABR), has been shown to be generally safe and well-tolerated in treating prostate cancer, with careful planning and setup techniques. However, long-term safety data, especially at higher doses, is still limited.26789
How is Daily-Adaptive SBRT different from other treatments for recurrent prostate cancer?
Daily-Adaptive SBRT is unique because it delivers high doses of radiation in fewer sessions, which can be more effective and convenient compared to traditional radiation therapy that uses lower doses over more sessions. This approach is particularly beneficial for targeting specific areas of recurrent prostate cancer, potentially improving outcomes and reducing the need for hormone therapy.23101112
Eligibility Criteria
This trial is for men who've had prostate cancer surgery but now have signs it's back. They need two PSA tests showing a level over 0.02 ng/dl, taken at least 30 days apart. Men with bowel inflammation, recent GI or urinary issues, high PSA levels (>10 ng/dl), spread of cancer beyond the pelvis, or previous pelvic radiation can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
Initial toxicity assessment phase to evaluate the safety of the novel radiation treatment schema
Treatment
Participants receive Daily-Adaptive with AI-assisted SBRT using Ethos Plan Adaptive technology
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of biochemical recurrence free survival and long-term side effects
Treatment Details
Interventions
- Daily-adaptive Stereotactic Body Radiation Therapy
Daily-adaptive Stereotactic Body Radiation Therapy is already approved in European Union, United States, Canada for the following indications:
- Primary prostate cancer
- Recurrent prostate cancer
- Low-risk prostate cancer
- Intermediate-risk prostate cancer
- Recurrent prostate cancer
- Primary prostate cancer
- Recurrent prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Varian Medical Systems
Industry Sponsor
Dow R. Wilson
Varian Medical Systems
Chief Executive Officer since 2012
MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University
Dr. Deepak Khuntia
Varian Medical Systems
Chief Medical Officer since 2020
MD from the University of Cambridge, PhD from the University of Leicester