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Radiation Therapy

Short vs Standard Duration Radiotherapy for Prostate Cancer

Phase 2

Recruiting

Led By Himanshu Nagar, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Ability to receive MRI-guided radiotherapy

KPS >=70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 10 years

Awards & highlights

Study Summary

This trial will compare two types of radiation therapy for men with prostate cancer that has come back after surgery. One type is given over 4 weeks and the other over 2 weeks. The study will look at side effects and health scores.

Who is the study for?

This trial is for men over 18 with prostate cancer that's come back after surgery. They need a detectable PSA level (unless they have node-positive disease), no distant metastatic disease, and must be able to undergo MRI-guided radiotherapy and fill out a quality of life questionnaire. Men with prior pelvic radiation, inflammatory bowel disease, or other serious cancers can't join.Check my eligibility

What is being tested?

The study compares two types of salvage radiotherapy for recurrent prostate cancer: one group receives treatment spread over 4 weeks (20 sessions) while the other gets it condensed into 2 weeks (5 sessions). The focus is on side effects related to urinary and bowel function, time until the cancer progresses again, and patient health scores.See study design

What are the potential side effects?

Potential side effects include issues with urinary and bowel functions due to the radiation therapy. These may vary depending on whether patients receive more intense treatment in fewer visits or less intense treatment across more visits.

Eligibility Criteria

Inclusion Criteria

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

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I can undergo MRI-guided radiotherapy.

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I am mostly able to care for myself.

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I have had a biopsy confirming no cancer spread outside my pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 10 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

Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)

Secondary outcome measures

Change in the number of patient reported GI-GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)

Number of patients who expired due to prostate cancer.

Overall survival (OS)

+1 more

Trial Design

2Treatment groups

Active Control

Group I: ARM 1 - 2 weeksActive Control1 Intervention

Patients will receive treatment to the prostate fossa +/- nodes in 32.5 Gy in 5 fractions. Patients receiving 32.5 Gy in 5 fractions cannot be treated on consecutive days.

Group II: ARM 2 - 4 weeksActive Control1 Intervention

Patients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,161 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,505 Patients Enrolled for Prostate Cancer

Viewray Inc.Industry Sponsor

12 Previous Clinical Trials

955 Total Patients Enrolled

1 Trials studying Prostate Cancer

136 Patients Enrolled for Prostate Cancer

Himanshu Nagar, M.D.Principal InvestigatorWeill Medical College of Cornell University

6 Previous Clinical Trials

383 Total Patients Enrolled

3 Trials studying Prostate Cancer

371 Patients Enrolled for Prostate Cancer

Media Library

20 days Radiation therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04422132 — Phase 2

Prostate Cancer Research Study Groups: ARM 1 - 2 weeks, ARM 2 - 4 weeks

Prostate Cancer Clinical Trial 2023: 20 days Radiation therapy Highlights & Side Effects. Trial Name: NCT04422132 — Phase 2

20 days Radiation therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04422132 — Phase 2

Frequently Asked Questions

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

How do I sign up for the clinical trial?

"Prostate cancer patients that are between 18 and 90 years old may be eligible for this study. The research team is currently trying to enroll 134 people in total."

Answered by AI

How many people can enroll in this clinical trial?

"That is accurate. The listing for this clinical trial on clinicaltrials.gov says that it is still looking for patients to enroll. This particular study was posted on September 24th, 2020 and updated as recently as June 29th, 2022. They are hoping to have 134 people participate at a single location."

Answered by AI

Are young adults eligible to participate in this experiment?

"As long as potential patients are above the age of 18 and have not yet reached their 90th birthday, they will be eligible for this trial."

Answered by AI

Is there a high risk of developing complications from ARM 1 - 2 weeks after treatment?

"While there is some safety data from Phase 2 trials, there is none currently supporting efficacy. Therefore, our team has rated the ARM 1-2 weeks as a 2."

Answered by AI

Are we still enrolling people in this experiment?

"Yes, the information on clinicaltrials.gov indicates that this clinical trial is actively recruiting patients. The clinical trial was originally posted on 9/24/2020 and was most recently updated on 6/29/2022. The clinical trial is enrolling 134 participants across 1 locations"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks

2020. "Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04422132.

All > Prostate Cancer New York