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Radiation
SBRT for Prostate Cancer
Phase 2
Recruiting
Led By Krishnan R Patel, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates a new radiation treatment called SBRT for men with early-stage prostate cancer. SBRT uses small gold seeds and advanced imaging to precisely target and kill cancer cells while minimizing damage to healthy tissue. The goal is to provide an effective treatment with fewer side effects compared to traditional methods. SBRT is a newer radiotherapy method for prostate cancer, developed to deliver high doses of radiation with improved precision.
Who is the study for?
This trial is for men aged 18+ with untreated localized prostate cancer that hasn't spread outside the gland. They must be able to consent, have a performance status indicating they can carry out daily activities, and agree to use effective contraception during and up to 120 days post-treatment. Exclusions include those planning other treatments like ADT or chemotherapy, with high-risk prostate cancer features, prior curative treatment for prostate cancer, certain infections unless treated and cured, or conditions preventing MRI scans.
What is being tested?
The trial tests focal therapy using SBRT on patients with a single tumor in the prostate. It aims to see if this targeted radiation approach leads to fewer side effects than whole-gland surgery or radiation. Participants will undergo two sessions of SBRT about one week apart without sedation and follow-up for two years including scans (MRI & PSMA PET/CT) and blood tests.
What are the potential side effects?
Potential side effects from SBRT may include urinary issues due to inflammation near the treated area, fatigue from radiation exposure, skin reactions at the site of treatment such as redness or soreness, bowel changes like diarrhea if nearby intestines are affected by radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathologic complete response rate
Secondary study objectives
Absolute and relative fraction of free PSA to bound PSA
Longitudinal quality of life (QoL)
Nadir PSA
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/Focal SBRTExperimental Treatment2 Interventions
Focal SBRT to the tumor focus within the prostate, with response assessed by biopsy and imaging, including 18F-DCFPyL PET/CT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-DCFPyL
2019
Completed Phase 3
~600
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for prostate cancer include surgery, traditional radiation therapy, and SBRT. Surgery involves removing the prostate gland to eliminate cancerous tissue but can lead to significant side effects.
Traditional radiation therapy uses high-energy rays to kill cancer cells but often affects surrounding healthy tissue, causing side effects. SBRT, a newer form of radiation therapy, delivers highly focused radiation doses directly to the tumor, minimizing damage to surrounding healthy tissue.
This precision reduces side effects and improves the quality of life for patients. Understanding these mechanisms helps prostate cancer patients make informed decisions about their treatment options, balancing effectiveness and potential side effects.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,538 Total Patients Enrolled
Krishnan R Patel, M.D.Principal InvestigatorNational Cancer Institute (NCI)
Media Library
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.