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Radiation Therapy

Short vs Standard Duration Radiotherapy for Prostate Cancer

Phase 2

Waitlist Available

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

Must not have

Patient with inflammatory bowel disease

Prior history of receiving pelvic radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 12 months, 24 months, 60 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have inflammatory bowel disease.

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I have had radiation therapy to my pelvic area before.

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I have had a narrowing of my bladder neck or urethra.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 12 months, 24 months, 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 12 months, 24 months, 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 12 months, 24 months, 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Overall survival (OS)

Time to progression (TTP)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met