Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer

NCT04984343 | Terminated Phase 2 DMC FDA Device

• 1 other identifier: 21-02023315
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 2

Brief Summary

The study is a randomized study that compares 5 radiation therapy treatments to 2 radiation therapy treatments in men with low or intermediate-risk prostate cancer.

Conditions

Prostate Cancer

Keywords

Low or intermediate risk prostate cancer; Definitive radiotherapy; MRI Linear accelerator

Outcome Measures

Primary Outcomes (1)

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

  The primary objective is to demonstrate that 2 treatments of radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms compared to 5 treatments of radiotherapy 2 years after treatment completion.

  Baseline, 24 months

Secondary Outcomes (15)

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

  Baseline, 1 week , 3months, 6 months, 12 months and 60 months

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

  Baseline, 1 week, 3months, 6 months, 12 months and 60 months

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

  Baseline, 1 week, 3months, 6 months, 12 months and 60 months

• Time to Progression (TTP)

  3 months

• Time to Progression (TTP)

  6 months

Study Arms (2)

5 radiation treatments - ARM 1

EXPERIMENTAL

Patients randomized to ARM 1 will receive 37.5 in 5 radiotherapy treatments.

Radiation: Radiation Therapy

2 radiation treatments - ARM 2

ACTIVE COMPARATOR

Patients randomized to ARM 2 will receive 25 Gy in 2 radiotherapy treatments.

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Eligible subjects will be randomly assigned to 5 or 2 fraction treatment groups in a 1:1 ratio using a computer-generated randomization scheme. After consent and eligibility verification, patients will undergo CT/MRI simulation and radiotherapy planning. Patients will receive treatment to the prostate +/- seminal vesicles per treating physician's discretion in either 37.5 Gy in 5 fractions or 25 Gy in 2 fractions. SIB use is at treating physician's discretion and should be concordant with imaging and biopsy findings with no PTV expansion. Subjects on 5 fraction arm should be treated on non-consecutive days. Subjects on the 2 fraction arm must have \>72 hours between beginning of each fraction.

2 radiation treatments - ARM 2; 5 radiation treatments - ARM 1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged \>=18 with histologically confirmed low or intermediate risk prostate cancer per NCCN guidelines.
• ECOG 0 - 1
• IPSS \< 18
• Ability to receive MRI-guided radiotherapy.
• Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
• Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator.

You may not qualify if:

• Prior history of receiving pelvic radiotherapy.
• Patient with history of inflammatory bowel disease.
• MRI Prostate Volume \> 80 cc
• MRI Stage \> T3a
• Unilateral or bilateral hip replacements.
• History of bladder neck or urethral stricture.
• TURP \< 8 weeks prior to radiotherapy
• Metastatic (pelvic nodal or distant) disease on CT, Bone, Fluciclovine, and/or PSMA PET scan

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Viewray Inc.: collaborator
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Genesis Care

Oxford, Oxford, OX4 6LB, United Kingdom

Location

Related Publications (1)

• Wolfe S, Diven MA, Marciscano AE, Zhou XK, Kishan AU, Steinberg ML, Miccio JA, Camilleri P, Nagar H. A randomized phase II trial of MR-guided prostate stereotactic body radiotherapy administered in 5 or 2 fractions for localized prostate cancer (FORT). BMC Cancer. 2023 Sep 30;23(1):923. doi: 10.1186/s12885-023-11430-z.

  PMID: 37777738 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Emily Weg, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: July 30, 2021
• Study Start: February 11, 2022
• Primary Completion: December 31, 2025
• Study Completion: February 19, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (1)