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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Low or intermediate risk prostate cancer, Definitive radiotherapy, MRI Linear accelerator

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Weill Cornell MedicineRecruiting
  • Genesis CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5 radiation treatments - ARM 1

2 radiation treatments - ARM 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 29, 2021
Last Updated
July 24, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Viewray Inc., Progenics Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04984343
Brief Title
Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
Acronym
FORT
Official Title
Randomized Phase II Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Viewray Inc., Progenics Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Low or intermediate risk prostate cancer, Definitive radiotherapy, MRI Linear accelerator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5 radiation treatments - ARM 1
Arm Type
Experimental
Arm Description
Patients randomized to ARM 1 will receive 37.5 in 5 radiotherapy treatments.
Arm Title
2 radiation treatments - ARM 2
Arm Type
Active Comparator
Arm Description
Patients randomized to ARM 2 will receive 25 Gy in 2 radiotherapy treatments.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
Description
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.
Time Frame
Baseline, 24 months
Secondary Outcome Measure Information:
Title
Change in the number of patient reported GI symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Description
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.
Time Frame
Baseline, 1 week , 3months, 6 months, 12 months and 60 months
Title
Change in the number of patient reported GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Description
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.
Time Frame
Baseline, 1 week, 3months, 6 months, 12 months and 60 months
Title
Change in the number of patient reported sexual symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Description
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 Frame
Baseline, 1 week, 3months, 6 months, 12 months and 60 months
Title
Time to Progression (TTP)
Description
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).
Time Frame
3 months
Title
Time to Progression (TTP)
Description
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).
Time Frame
6 months
Title
Time to Progression (TTP)
Description
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).
Time Frame
12 months
Title
Time to Progression (TTP)
Description
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).
Time Frame
60 months
Title
Compare Overall Survival Rates
Description
Compare Overall Survival (OS) in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.
Time Frame
3 months
Title
Compare Overall Survival Rates
Description
Compare Overall Survival (OS) in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.
Time Frame
6 months
Title
Compare Overall Survival Rates
Description
Compare Overall Survival (OS) in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.
Time Frame
12 months
Title
Compare Overall Survival Rates
Description
Compare Overall Survival (OS) in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.
Time Frame
60 months
Title
prostate cancer specific survival
Description
compare prostate cancer specific survival in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.
Time Frame
3 months
Title
prostate cancer specific survival
Description
compare prostate cancer specific survival in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.
Time Frame
6 months
Title
prostate cancer specific survival
Description
compare prostate cancer specific survival in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.
Time Frame
12 months
Title
prostate cancer specific survival
Description
compare prostate cancer specific survival in patients among the two arms, 37.5 Gy in 5 fractions and 25 Gy in 2 fractions.
Time Frame
60 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pragya Yadav, Ph.D
Phone
6469622199
Email
pry2003@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel Downing, Ph.D.
Phone
6469622196
Email
rad4012@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Himanshu Nagar, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Downing, Ph.D
Phone
646-962-2196
Email
rad4012@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Pragya Yadav, Ph.D.
Phone
646-962-2199
Email
pry2003@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Himanshu Nagar, M.D.
Facility Name
Genesis Care
City
Oxford
ZIP/Postal Code
OX4 6LB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabia Bhatti
Email
Rabia.Bhatti@genesiscare.co.uk
First Name & Middle Initial & Last Name & Degree
Philip Camilleri, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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