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Radiation

Hypofractionated Radiation for Prostate Cancer

Q: Are there any opportunities for involvement in this experiment still available?

<p>According to the research found on clinicaltrials.gov, this particular medical trial is no longer open for recruitment. It was initially posted in May 2018 and last updated June 2022; however there are 1,270 other trials that require participants at present time.</p>

Q: What potential risks should be considered with Androgen Suppression?

<p>Based on the Phase 2 status of Androgen Suppression, our team at Power has assigned a score of 2 for its safety. This indicates that there is some evidence confirming its security although no data to support efficacy yet exists.</p>

Phase 2

Waitlist Available

Led By Carlos E. Vargas, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologic stages T2-T3b, N0-Nx-N1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed.])

One or more high risk features including: seminal vesicle invasion, extracapsular extension, positive margins, or a PSA post surgery between 0.2 and < 2.0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial looks at a new way of giving radiation to prostate cancer patients who have had surgery to remove the prostate. The new way uses higher doses of radiation given over a shorter time period. Researchers want to see if this is an effective treatment with fewer side effects.

Who is the study for?

Men with prostate cancer showing high-risk features after surgery can join this trial. They should have no history of chemotherapy for prostate cancer, heart issues in the last 6 months, or major illnesses that could affect participation. No prior pelvic radiation or long-term androgen suppression therapy is allowed.Check my eligibility

What is being tested?

The study tests if a shorter period of intense radiation therapy combined with hormone suppression can effectively treat prostate cancer post-surgery. It aims to see if this approach kills more tumor cells while causing fewer side effects.See study design

What are the potential side effects?

Potential side effects may include skin irritation at the treatment site, fatigue, bowel and urinary issues due to radiation, and hormonal changes from androgen suppression like hot flashes or reduced sexual desire.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is at a specific stage according to my pathology report.

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My prostate cancer has high-risk features like spread or PSA levels between 0.2 and <2.0 after surgery.

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My PSA level is below 2 ng/ml, measured after surgery.

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My prostate cancer was confirmed by a tissue examination during surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Freedom from failure (FF)

Secondary outcome measures

Acute grade 2 or higher and grade 3 or higher genitourinary (GU) and gastrointestinal (GI) toxicity

Disease-free survival

Distant metastasis

+8 more

Other outcome measures

Development of quality assurance process for prostate proton therapy

Dose volume relationship of normal structures with toxicity

Estimation of prostate and normal structure movement

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group III (radiation therapy, androgen suppression therapy)Experimental Treatment4 Interventions

Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.

Group II: Group II (radiation therapy, androgen suppression therapy)Experimental Treatment4 Interventions

Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.

Group III: Group I (hypofractionated radiation therapy)Experimental Treatment3 Interventions

Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Androgen Suppression

2014

Completed Phase 2

~60

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,732 Total Patients Enrolled

34 Trials studying Prostate Cancer

8,388 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,101 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 Patients Enrolled for Prostate Cancer

Carlos E. Vargas, M.D.Principal InvestigatorMayo Clinic

4 Previous Clinical Trials

313 Total Patients Enrolled

Media Library

$Hypofractionated Radiation Therapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03570827 — Phase 2$

$Prostate Cancer Research Study Groups: Group III (radiation therapy, androgen suppression therapy), Group I (hypofractionated radiation therapy), Group II (radiation therapy, androgen suppression therapy)$

$Prostate Cancer Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT03570827 — Phase 2$

$Hypofractionated Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03570827 — Phase 2$

Frequently Asked Questions

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

Are there any opportunities for involvement in this experiment still available?

"According to the research found on clinicaltrials.gov, this particular medical trial is no longer open for recruitment. It was initially posted in May 2018 and last updated June 2022; however there are 1,270 other trials that require participants at present time."

Answered by AI

What potential risks should be considered with Androgen Suppression?

"Based on the Phase 2 status of Androgen Suppression, our team at Power has assigned a score of 2 for its safety. This indicates that there is some evidence confirming its security although no data to support efficacy yet exists."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy

2018. "Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03570827.