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Radiation

Hypofractionated Radiotherapy for Prostate Cancer

Phase 1
Waitlist Available
Led By Deborah E Citrin, 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
Age greater than or equal to 18 years
ECOG performance status less than or equal to 1 (Karnofsky greater than or equal to 60)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks after radiation
Awards & highlights

Study Summary

This trial is testing a shorter schedule for radiation therapy for people with prostate cancer that has come back after surgery. The goal is to find the shortest schedule that people can tolerate without strong side effects.

Who is the study for?
Men over 18 who've had their prostate removed and need radiation can join. They must use birth control, have a stable health status (ECOG ≤1), and no history of severe immune deficiency or opportunistic infections if HIV+. No current participation in other trials, prior pelvic radiation, inflammatory bowel disease, lupus, scleroderma, genetic hypersensitivity to radiation or metastases outside the pelvis are allowed.Check my eligibility
What is being tested?
Researchers are testing shorter schedules of post-prostatectomy radiotherapy to see if they're as effective with fewer side effects. Some patients will receive standard doses while others get an increased dose focused on tumor areas identified by scans.See study design
What are the potential side effects?
Potential side effects include skin irritation at the treatment site, fatigue, urinary issues like frequency or discomfort during urination, bowel changes such as diarrhea or rectal bleeding/pain due to inflammation from the radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am mostly able to care for myself and carry out daily activities.
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I need radiation after prostate surgery due to cancer signs or specific surgical findings.
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My prostate cancer diagnosis was confirmed through lab tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks after radiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks after radiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Define the maximum tolerated dose (MTD)
Secondary outcome measures
List of adverse event frequency
Proportion of patients that have improvement in quality of life after treatment
The rate of PSA control

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Prostate bed irradiation onlyExperimental Treatment1 Intervention
Dose to prostate bed irradiation only
Group II: 1/Prostate bed with integrated boostExperimental Treatment1 Intervention
Dose to prostate bed with integrated boost

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,615 Previous Clinical Trials
40,918,595 Total Patients Enrolled
559 Trials studying Prostate Cancer
507,126 Patients Enrolled for Prostate Cancer
Deborah E Citrin, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
742 Total Patients Enrolled
4 Trials studying Prostate Cancer
410 Patients Enrolled for Prostate Cancer

Media Library

Dose to prostate bed irradiation only (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03388619 — Phase 1
Prostate Cancer Research Study Groups: 1/Prostate bed with integrated boost, 2/Prostate bed irradiation only
Prostate Cancer Clinical Trial 2023: Dose to prostate bed irradiation only Highlights & Side Effects. Trial Name: NCT03388619 — Phase 1
Dose to prostate bed irradiation only (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03388619 — Phase 1

Frequently Asked Questions

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

What are the risks associated with Dose to prostate bed with integrated boost?

"Dose to prostate bed with integrated boost is still being studied for efficacy in Phase 1 trials, so its safety rating is a 1."

Answered by AI

How many people are included in this clinical trial at present?

"That is correct. As indicated on the website clinicaltrials.gov, this study was posted on 1/17/2018 and updated on 10/15/2022. They are currently looking for 48 patients from 1 location."

Answered by AI

Is this research still looking for participants?

"The study, which was originally posted on January 17th 2018 and updated October 15th of this year, is still recruiting patients."

Answered by AI
Recent research and studies
~4 spots leftby Mar 2025