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

Weill Cornell Medicine (WCM)

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04984343

21-02023315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

5 radiation treatments - ARM 1

Experimental group

Description:

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

Treatment:

Radiation: Radiation Therapy

2 radiation treatments - ARM 2

Active Comparator group

Description:

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

Treatment:

Radiation: Radiation Therapy