FORT Study
Research type
Research Study
Full title
Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
IRAS ID
317471
Contact name
Himanshu Nagar
Contact email
Sponsor organisation
Weill Cornell Medicine
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 8 months, 1 days
Research summary
This is a randomised study in men aged over 18 with low or medium-risk prostate cancer.
The purpose of this study is to assess the potential benefit of limiting radiation dose received by normal tissues, namely bladder and rectum, with advanced MR (magnetic resonance) image guidance, and to compare urinary and bowel side effects of radiotherapy in 5 treatments to 2 treatments. The investigators are also looking at progression-free survival (prostate cancer cure and control) and the quality of life (health scores). The trial is important because it lays the foundation to potentially redefine the standard of care to include 2 fraction radiotherapy treatment which reduces the treatment burden on the patient.
Participants will be in the study for up to 5 years with regular follow-up visits every 3 months for the first 2 years and at the 5th year (60-month) post treatment follow-up.
Participants will undergo radiation therapy (either 5 or 2 fractions) and complete Quality of life surveys: EPIC, IPSS and EQ-5D at every follow-up visit. Optional research blood samples will be collected at baseline (before radiation therapy), at end of radiation therapy visit, at 6-month, 12-month, 24-month and at 60-month follow-up visits. Optional urine samples will be collected at baseline visit, end of radiation therapy visit and at 24-month follow-up visit.
Around 136 participants will take part in this study in total. The study is being run at three sites in the United States and at Genesis Care in the UK. Around 20 participants will be recruited at the Genesis Care Oxford site.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
23/NE/0092
Date of REC Opinion
12 May 2023
REC opinion
Favourable Opinion