Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Sharanya Chandrasekhar
- 646-962-3110
- [email protected]
Principal Investigator
- Himanshu Nagar, M.D.
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
Outcome Measures
Primary Outcome Measures
Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
Secondary Outcome Measures
Change in the number of patient reported GI symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Change in the number of patient reported GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Change in the number of patient reported sexual symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Time to Progression (TTP)
Time to Progression (TTP)
Time to Progression (TTP)
Time to Progression (TTP)
Compare Overall Survival Rates
Compare Overall Survival Rates
Compare Overall Survival Rates
Compare Overall Survival Rates
prostate cancer specific survival
prostate cancer specific survival
prostate cancer specific survival
prostate cancer specific survival
Timeline
Last Updated
June 26, 2024Start Date
July 30, 2021Today
January 16, 2025Completion Date ( Estimated )
December 31, 2027
Sponsors of this trial
Lead Sponsor
Weill Medical College of Cornell UniversityCollaborating Sponsors
Viewray Inc., Progenics Pharmaceuticals, Inc.