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Radiation

SBRT + 18F-DCFPyL for Prostate Adenocarcinoma

National Institutes of Health Clinical Center, Bethesda, MD
Targeting 3 different conditionsStereotactic Body Radiation Therapy +1 morePhase 2RecruitingLed by Krishnan R Patel, M.D.Research Sponsored by National Cancer Institute (NCI)

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.

Eligible Conditions
  • Prostate Cancer
  • Prostate Adenocarcinoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have a single focal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET/CT imaging which is correlated with a positive targeted biopsy.
Select...
You have histologically confirmed, low or intermediate risk prostatic adenocarcinoma.

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

Awards & 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
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~770
18F-DCFPyL
2019
Completed Phase 3
~410

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,492 Previous Clinical Trials
41,267,537 Total Patients Enrolled
556 Trials studying Prostate Cancer
506,050 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 > Sbrt > Prostate Cancer
~28 spots leftby Dec 2027
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