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

Phase 2

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Radiation Therapy

• Registration Number: NCT04984343
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

This study is a randomized non-inferiority trial comparing 5 to 2 radiotherapy treatments using an MRI linear accelerator for men with low or intermediate-risk prostate cancer electing for definitive radiotherapy.

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-07-30
• Study Start: 2022-02-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 33

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 radiation treatments - ARM 1	Radiation Therapy	Patients randomized to ARM 1 will receive 37.5 in 5 radiotherapy treatments.
2 radiation treatments - ARM 2	Radiation Therapy	Patients randomized to ARM 2 will receive 25 Gy in 2 radiotherapy treatments.

Primary Outcome Measures

Name	Time	Method
Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)	Baseline, 24 months	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.

Secondary Outcome Measures

Name	Time	Method
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	Compare patient-reported GI symptoms using the EPIC at end of RT and 3, 6, 12, and 60 months from end of treatment.; Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.; Adverse events can be unexpected or expected, related to treatment.
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	Compare patient-reported sexual symptoms using the EPIC at end of RT and 3, 6, 12, 24, and 60 months from end of treatment.; Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.; Adverse events can be unexpected or expected, related to treatment.
Time to Progression (TTP)	60 months	Compare time to progression (TTP) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).
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	Compare patient-reported GU symptoms using the EPIC at end of RT and 3, 6, 12, and 60 months from end of treatment.; Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.; Adverse events can be unexpected or expected, related to treatment.
Compare Overall Survival Rates	60 months	Compare Overall Survival (OS) in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.
prostate cancer specific survival	60 months	compare prostate cancer specific survival in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.

Trial Locations

Locations (2)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Genesis Care; 🇬🇧 Oxford, United Kingdom