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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

Study Summary

This trial will test a new type of radiation (SBRT) to treat prostate cancer with fewer side effects than standard treatments. Participants will have scans and blood tests, receive radiation in two sessions, then be followed-up for two years.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic complete response rate
Secondary outcome measures
Absolute and relative fraction of free PSA to bound PSA
Longitudinal quality of life (QoL)
Nadir PSA
+3 more

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
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
18F-DCFPyL
2019
Completed Phase 3
~350

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,963 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,053 Patients Enrolled for Prostate Cancer
Krishnan R Patel, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Media Library

Stereotactic Body Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05616650 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks could be associated with 1/Focal SBRT treatments?

"We assign a safety score of 2 to 1/Focal SBRT, as phase two trials only provide evidence for the drug's security and not its efficacy."

Answered by AI

Has recruitment for this experiment begun?

"As indicated on clinicaltrials.gov, this medical investigation is no longer actively seeking participants; the initial posting was made on November 29th 2022 with the latest update being logged eleven days prior. However, there are over two thousand other trials that still require volunteers at present."

Answered by AI

Who else is applying?

What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
New York
California
Recent research and studies
clinicaltrials.govStudy
Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor
2023. "Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05616650.
All > Prostate Cancer
~28 spots leftby Dec 2027
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