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Radiation Therapy

Radiation Therapy for Prostate Cancer (FORT Trial)

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
ECOG score of 0 - 1
Ability to receive MRI-guided radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 3months, 6 months, 12 months and 60 months
Awards & highlights

FORT Trial Summary

This trial is testing if adding more radiation treatments to the standard 2 will improve cancer outcomes in men with low or intermediate-risk prostate cancer.

Who is the study for?
This trial is for men over 18 with low or intermediate-risk prostate cancer, who are generally healthy and can undergo MRI-guided radiotherapy. They should not have had pelvic radiation before, no large prostate on MRI (>80 cc), no recent TURP surgery, no metastatic disease, and no history of inflammatory bowel disease or hip replacements.Check my eligibility
What is being tested?
The study compares two different schedules of MRI-guided adaptive radiotherapy treatments for prostate cancer: one group will receive five treatments while the other group will receive just two. The goal is to see which treatment schedule works best.See study design
What are the potential side effects?
Potential side effects from the radiation therapy may include skin irritation in the treated area, fatigue, urinary issues like increased frequency or discomfort during urination, bowel changes such as diarrhea or rectal bleeding, and erectile dysfunction.

FORT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I can undergo MRI-guided radiotherapy.
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I am a man over 18 with low or intermediate risk prostate cancer.

FORT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 3months, 6 months, 12 months and 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 3months, 6 months, 12 months and 60 months 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 symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Change in the number of patient reported GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Change in the number of patient reported sexual symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
+3 more

FORT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 5 radiation treatments - ARM 1Experimental Treatment1 Intervention
Patients randomized to ARM 1 will receive 37.5 in 5 radiotherapy treatments.
Group II: 2 radiation treatments - ARM 2Active Control1 Intervention
Patients randomized to ARM 2 will receive 25 Gy in 2 radiotherapy treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Progenics Pharmaceuticals, Inc.Industry Sponsor
33 Previous Clinical Trials
4,222 Total Patients Enrolled
17 Trials studying Prostate Cancer
1,656 Patients Enrolled for Prostate Cancer
Viewray Inc.Industry Sponsor
12 Previous Clinical Trials
953 Total Patients Enrolled
1 Trials studying Prostate Cancer
134 Patients Enrolled for Prostate Cancer
Weill Medical College of Cornell UniversityLead Sponsor
1,060 Previous Clinical Trials
1,316,027 Total Patients Enrolled
48 Trials studying Prostate Cancer
34,475 Patients Enrolled for Prostate Cancer

Media Library

Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04984343 — Phase 2
Prostate Cancer Research Study Groups: 2 radiation treatments - ARM 2, 5 radiation treatments - ARM 1
Prostate Cancer Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04984343 — Phase 2
Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984343 — Phase 2
~53 spots leftby Dec 2025
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