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Clinical Trial NCT04984343 (FORT) for Prostate Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer (FORT) Phase 2 33 Randomized Adaptive Design
Clinical Trial NCT04984343 (FORT) is designed to study Treatment for Prostate Cancer. It is a Phase 2 interventional study that is active, not recruiting, having started on February 11, 2022, with plans to enroll 33 participants. Led by Weill Medical College of Cornell University, it is expected to complete by December 31, 2028. The latest data from ClinicalTrials.gov was last updated on May 21, 2025.
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.
Official Title
Randomized Phase II Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
Conditions
Prostate CancerPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- FORT
- 21-02023315
NCT ID Number
Start Date (Actual)
2022-02-11
Last Update Posted
2025-05-21
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
33
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Low or intermediate risk prostate cancer
Definitive radiotherapy
MRI Linear accelerator
Definitive radiotherapy
MRI Linear accelerator
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimental5 radiation treatments - ARM 1 Patients randomized to ARM 1 will receive 37.5 in 5 radiotherapy treatments. | Radiation Therapy 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. S...Show More |
Active Comparator2 radiation treatments - ARM 2 Patients randomized to ARM 2 will receive 25 Gy in 2 radiotherapy treatments. | Radiation Therapy 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. S...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in the number of patient reported GI symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC) | 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. | 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) | 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. | 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) | 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. | Baseline, 1 week, 3months, 6 months, 12 months and 60 months |
Time to Progression (TTP) | 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). | 3 months |
Time to Progression (TTP) | 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). | 6 months |
Time to Progression (TTP) | 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). | 12 months |
Time to Progression (TTP) | 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). | 60 months |
Compare Overall Survival Rates | Compare Overall Survival (OS) in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions. | 3 months |
Compare Overall Survival Rates | Compare Overall Survival (OS) in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions. | 6 months |
Compare Overall Survival Rates | Compare Overall Survival (OS) in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions. | 12 months |
Compare Overall Survival Rates | Compare Overall Survival (OS) in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions. | 60 months |
prostate cancer specific survival | compare prostate cancer specific survival in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions. | 3 months |
prostate cancer specific survival | compare prostate cancer specific survival in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions. | 6 months |
prostate cancer specific survival | compare prostate cancer specific survival in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions. | 12 months |
prostate cancer specific survival | compare prostate cancer specific survival in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions. | 60 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
- 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.
- 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
Weill Medical College of Cornell University- Viewray Inc.
- Progenics Pharmaceuticals, Inc.
No contact data.
2 Study Locations in 2 Countries
New York
Weill Cornell Medicine, New York, New York, 10065, United States
Genesis Care, Oxford, OX4 6LB, United Kingdom