AzTrials
AzTrials

Prostate CancerPhase 2FORTNCT04984343

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

A Phase 2 study testing Radiation Therapy in people with Prostate Cancer, run by Weill Medical College of Cornell University at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesin 2 countries
Study dates
11 Feb 2022to 19 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

United Kingdom1 site

  • Genesis Care

    Oxford, Oxford, OX4 6LB

Other trials in United Kingdom

About this study

Official title: Randomized Phase II Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Radiation Therapy
Keywords
Low or intermediate risk prostate cancer, Definitive radiotherapy, MRI Linear accelerator
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation TherapyRadiation

    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.

Study groups in NCT04984343
Study groupRoleWhat they receive
5 radiation treatments - ARM 1ExperimentalPatients randomized to ARM 1 will receive 37.5 in 5 radiotherapy treatments.
Receives: Radiation: Radiation Therapy
2 radiation treatments - ARM 2Active comparatorPatients randomized to ARM 2 will receive 25 Gy in 2 radiotherapy treatments.
Receives: Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 24 months

Secondary outcomes (15)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

    Measured: 3 months

  5. 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).

    Measured: 6 months

  6. 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).

    Measured: 12 months

  7. 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).

    Measured: 60 months

  8. 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.

    Measured: 3 months

  9. 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.

    Measured: 6 months

  10. 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.

    Measured: 12 months

  11. 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.

    Measured: 60 months

  12. 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.

    Measured: 3 months

  13. 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.

    Measured: 6 months

  14. 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.

    Measured: 12 months

  15. 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.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start11 Feb 2022
  3. Primary completion31 Dec 2025
  4. Study completion19 Feb 2026

Why it stopped: The study was closed prematurely due to low enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04984343
Sponsor's protocol ID
21-02023315
Acronym
FORT
Status last verified
Apr 2026
First submitted
29 Jul 2021
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 37777738

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation Therapy in people with Prostate Cancer, run by Weill Medical College of Cornell University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was closed prematurely due to low enrollment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC) (time frame: Baseline, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04984343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in