Open Actively Recruiting

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

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
90 Years

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

Join this Trial

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Study Stats
Protocol No.
21-002021
Category
Oncology
Radiation Oncology
Contact
Vincent Basehart
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04984343
For detailed technical eligibility, visit ClinicalTrials.gov.