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Brachytherapy
HDR Monotherapy for Prostate Cancer
N/A
Waitlist Available
Led By I-Chow Hsu, MD
Research Sponsored by University of California, San Francisco
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 up to 6 months
Awards & highlights
Study Summary
This trial is studying a way to make radiation therapy safer and more efficient, potentially reducing resources and stress on departments.
Who is the study for?
Men aged 18+ with low to intermediate risk prostate cancer, who haven't had treatment for it or androgen deprivation therapy. They must be fit enough for the procedure (ECOG <2), able to consent, and if HIV/HBV/HCV positive, they need controlled viral loads. Those with other cancers can join if it doesn't affect this trial's safety or results.Check my eligibility
What is being tested?
The study is testing a high dose rate (HDR) brachytherapy as the only treatment for prostate cancer given in two sessions just 3 hours apart. This approach could make treatment quicker and easier on healthcare systems compared to current methods where treatments are spaced further apart.See study design
What are the potential side effects?
Potential side effects of HDR brachytherapy may include discomfort at the implant site, urinary issues like frequency or urgency, bowel changes, erectile dysfunction, and fatigue. These vary by individual.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with treatment-related adverse events
Secondary outcome measures
Mean Change in International Prostate Symptom Score (IPSS) over time
Mean Prostate Specific Antigen (PSA) Nadir
Mean Time to PSA Nadir
Trial Design
1Treatment groups
Experimental Treatment
Group I: HDR brachytherapyExperimental Treatment1 Intervention
Participants will receive the same radiotherapy technique, methods, and delivery will as standard of care 3 hours apart instead of receiving the radiotherapy on separate days.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,503 Previous Clinical Trials
15,236,638 Total Patients Enrolled
52 Trials studying Prostate Cancer
17,033 Patients Enrolled for Prostate Cancer
I-Chow Hsu, MDPrincipal InvestigatorUniversity of California, San Francisco
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had prostate surgery within the last 6 months.I have received treatment for prostate cancer before.My pre-treatment assessment indicates I might not be suitable for a specific radiation therapy.I am mostly self-sufficient and can carry out daily activities.My hepatitis B virus load is undetectable with treatment.My prostate cancer diagnosis was confirmed through lab tests.I cannot have general anesthesia due to health risks.I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.I cannot undergo radiotherapy due to health reasons.My cancer is considered low to intermediate risk.I am 18 years old or older.I have had cryosurgery or cryotherapy on my prostate before.My doctor has approved me for a specific radiation therapy treatment.I have undergone hormone therapy for cancer.I had hepatitis C but am now cured, or I am being treated with an undetectable viral load.I have not received any treatment for prostate cancer or hormone therapy.I have another cancer, but it won't affect this trial's treatment.
Research Study Groups:
This trial has the following groups:- Group 1: HDR brachytherapy
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 participants still being accepted for the clinical trial?
"Clinicaltrials.gov confirms that this medical research endeavour is not currently accepting patients, having been originally posted on April 1st 2023 and last updated December 27th 2022. Despite the inactivity of this study, there are an abundance of other clinical trials actively recruiting right now – a total of 1922 to be exact."
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