Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer (NCT04984343) | Clinical Trial Compass
TerminatedPhase 2
Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
Stopped: The study was closed prematurely due to low enrollment.
United States, United Kingdom33 participantsStarted 2022-02-11
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexMALE
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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
What they're measuring
1
Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
Timeframe: Baseline, 24 months
Trial details
NCT IDNCT04984343
SponsorWeill Medical College of Cornell University