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

Clinicaltrials.gov ID: NCT04984343
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age 18 - 90 Years
b-bullseye-arrow Enrollments 136

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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)

Time Frame: Baseline, 24 months

Secondary Outcome Measures

Change in the number of patient reported GI symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)

Time Frame: Baseline, 1 week , 3months, 6 months, 12 months and 60 months

Change in the number of patient reported GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)

Time Frame: Baseline, 1 week, 3months, 6 months, 12 months and 60 months

Change in the number of patient reported sexual symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)

Time Frame: Baseline, 1 week, 3months, 6 months, 12 months and 60 months

Time to Progression (TTP)

Time Frame: 3 months

Time to Progression (TTP)

Time Frame: 6 months

Time to Progression (TTP)

Time Frame: 12 months

Time to Progression (TTP)

Time Frame: 60 months

Compare Overall Survival Rates

Time Frame: 3 months

Compare Overall Survival Rates

Time Frame: 6 months

Compare Overall Survival Rates

Time Frame: 12 months

Compare Overall Survival Rates

Time Frame: 60 months

prostate cancer specific survival

Time Frame: 3 months

prostate cancer specific survival

Time Frame: 6 months

prostate cancer specific survival

Time Frame: 12 months

prostate cancer specific survival

Time Frame: 60 months

Timeline

  • Last Updated
    June 26, 2024
  • Start Date
    July 30, 2021
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    December 31, 2027

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