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Radiation
Stereotactic Body Radiation Therapy for Recurrent Prostate Cancer (DASBRT-RPC Trial)
Phase 2
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 years
Awards & highlights
DASBRT-RPC Trial Summary
This trial is testing a new radiation technique for prostate cancer after surgery that delivers higher doses more quickly, with the help of AI.
Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing a new way to do radiation called Daily-adaptive Stereotactic Body Radiation Therapy (SBRT) using AI and Ethos Plan Adaptive technology. It aims to treat recurrent prostate cancer after surgery more precisely in fewer sessions than traditional methods.See study design
What are the potential side effects?
While not detailed here, SBRT side effects may include fatigue, skin reactions in the treated area, frequent urination with possible discomfort or burning sensation during urination, loose stools or diarrhea.
DASBRT-RPC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
The primary objective of the full enrollment Phase II component is to report biochemical recurrence free survival (bPFS).
Secondary outcome measures
Distant metastasis free survival
Long term side effects
Need for long term anti-testosterone therapy
Other outcome measures
Planning parameters and techniques
DASBRT-RPC Trial Design
2Treatment groups
Experimental Treatment
Group I: 2- Pelvic nodal with or without a prostate bed recurrenceExperimental Treatment1 Intervention
Patients who have a radiologic recurrence of prostate cancer in the pelvic node region
Group II: 1 - Prostate bed only recurrenceExperimental Treatment1 Intervention
Patients with confirmed radiologic recurrence of their prostate cancer in the defined region of the previous prostate surgery - commonly referred to as the prostate surgical bed.
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Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,170 Total Patients Enrolled
8 Trials studying Prostate Cancer
557 Patients Enrolled for Prostate Cancer
Varian Medical SystemsIndustry Sponsor
59 Previous Clinical Trials
3,699 Total Patients Enrolled
4 Trials studying Prostate Cancer
411 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was hospitalized for a urinary problem in the last 3 months.I was hospitalized for a stomach or intestine problem in the last 3 months.I had surgery for prostate cancer.My prostate cancer has returned in the area where my prostate was or nearby lymph nodes.My prostate cancer has come back in the area where my prostate was or in the surgical field.I have had radiation therapy to my pelvic area.My cancer has spread to other parts of my body.I have inflammatory bowel disease.
Research Study Groups:
This trial has the following groups:- Group 1: 1 - Prostate bed only recurrence
- Group 2: 2- Pelvic nodal with or without a prostate bed recurrence
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings left for individuals to participate in this clinical experiment?
"The details listed on clinicaltrials.gov reveal that this particular research study is not currently recruiting participants; the initial posting was November 24th, 2023 with the last edit occurring on July 7th of that same year. However, there are over two thousand other medical trials actively looking for individuals to participate in their studies."
Answered by AI
Is the 1 - Prostate bed only recurrence treatment recognized by the US Food and Drug Administration?
"There is some evidence backing the safety of 1 - Prostate bed only recurrence, therefore it achieved a score of 2. However, as this trial is still in Phase 2 there has not yet been any data collected to support efficacy."
Answered by AI
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