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Radiation Therapy

Stereotactic Ablative Radiotherapy for Prostate Cancer (DAPPER Trial)

N/A

Recruiting

Led By Bradley J Stish

Research Sponsored by Mayo Clinic

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 up to 5 years

Awards & highlights

DAPPER Trial Summary

This trial evaluates the safety & effectiveness of radiation therapy (x-rays) to the prostate fossa & pelvic lymph nodes after prostatectomy to better target tumors & minimize exposure to normal tissue.

Who is the study for?

Men over 18 with prostate cancer who've had their prostate surgically removed and are now facing a rise in PSA levels, indicating potential remaining cancer. They must be able to handle daily activities with some limitations (ECOG PS ≤2), fill out questionnaires, give informed consent, and follow the study's check-up schedule. Men with untreated widespread cancer, recent chemotherapy, previous high-dose pelvic radiation, life expectancy under 5 years due to other diseases, decision-making impairments or non-adherence issues can't join.Check my eligibility

What is being tested?

The DAPPER Study is testing if using Stereotactic Ablative Radiotherapy (SABR) combined with daily adaptive techniques can safely target leftover tumor areas while minimizing damage to healthy tissue in men post-prostatectomy. This involves advanced imaging like MRI and PET/CT scans for precise treatment adjustments.See study design

What are the potential side effects?

Potential side effects include skin reactions in treated areas, fatigue from radiation therapy, bowel and bladder changes such as increased frequency or discomfort during use. There may also be risks associated with frequent imaging tests used for adapting the therapy.

DAPPER Trial 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

Observe Grade 3 genitourinary and gastrointestinal toxicity rate to demonstrate safety of daily adaptive online replanning

Secondary outcome measures

Assess patient reported changes in urinary, bowel, and sexual outcomes following protocol treatment with the Expanded Prostate Cancer Index Composite-26 (EPIC-26) instrument.

Biochemical failure

Change in patient reported urinary, bowel, and sexual outcomes following protocol treatment with the Expanded Prostate Cancer Index Composite-26 (EPIC-26) instrument.

+3 more

DAPPER Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (daily adaptive online replanning, SBRT)Experimental Treatment6 Interventions

Patients undergo daily adaptive online replanning for SBRT to the prostate fossa and pelvic lymph nodes on study. Patients also undergo MRI and may undergo PET/CT during screening.

Group II: Group I (daily adaptive online replanning, SBRT)Experimental Treatment6 Interventions

Patients undergo daily adaptive online replanning for SBRT to the prostate fossa on study. Patients also undergo MRI and may undergo PET/CT during screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Image-Guided Adaptive Radiation Therapy

2015

Completed Early Phase 1

~50

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,090 Total Patients Enrolled

34 Trials studying Prostate Cancer

8,388 Patients Enrolled for Prostate Cancer

Bradley J StishPrincipal InvestigatorMayo Clinic in Rochester

1 Previous Clinical Trials

45 Total Patients Enrolled

Bradley J. Stish, M.D.Principal InvestigatorMayo Clinic in Rochester

2 Previous Clinical Trials

194 Total Patients Enrolled

1 Trials studying Prostate Cancer

154 Patients Enrolled for Prostate Cancer

Media Library

Stereotactic Body Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05830838 — N/A

Prostate Cancer Research Study Groups: Group I (daily adaptive online replanning, SBRT), Group II (daily adaptive online replanning, SBRT)

Prostate Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT05830838 — N/A

Stereotactic Body Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05830838 — N/A

Frequently Asked Questions

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

Are there any vacancies currently available for enrolment in this research study?

"According to clinicaltrials.gov this study is no longer enrolling patients, having been first posted on May 30th 2023 and last updated April 13th of the same year. However, there are presently 1265 other medical trials actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer

Bradley (Brad) Stish 2023. "Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05830838.