Clinical trial NCT04984343: Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
Official title: Randomized Phase II Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Low or intermediate risk prostate cancer
Definitive radiotherapy
MRI Linear accelerator
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Viewray Inc.
name: Progenics Pharmaceuticals, Inc.
First posted: 2021-07-30
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: Baseline, 24 months
Secondary outcomes:
measure: Change in the number of patient reported GI symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: Baseline, 1 week , 3months, 6 months, 12 months and 60 months
measure: Change in the number of patient reported GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: Baseline, 1 week, 3months, 6 months, 12 months and 60 months
measure: Change in the number of patient reported sexual symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: Baseline, 1 week, 3months, 6 months, 12 months and 60 months
measure: Time to Progression (TTP)
timeFrame: 3 months
measure: Time to Progression (TTP)
timeFrame: 6 months
measure: Time to Progression (TTP)
timeFrame: 12 months
measure: Time to Progression (TTP)
timeFrame: 60 months
measure: Compare Overall Survival Rates
timeFrame: 3 months
measure: Compare Overall Survival Rates
timeFrame: 6 months
measure: Compare Overall Survival Rates
timeFrame: 12 months
measure: Compare Overall Survival Rates
timeFrame: 60 months
measure: prostate cancer specific survival
timeFrame: 3 months
measure: prostate cancer specific survival
timeFrame: 6 months
measure: prostate cancer specific survival
timeFrame: 12 months
measure: prostate cancer specific survival
timeFrame: 60 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Oxford
country: United Kingdom
facility: Genesis Care
Study officials:
affiliation: Weill Medical College of Cornell University
name: Emily Weg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: