Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04422132

Sponsor: Weill Medical College of Cornell University

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 90 Years
  • Gender: Male

Inclusion Criteria:

  • Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease.
  • KPS >=70
  • Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan < 9 months prior to enrollment. Patients with positive pelvic lymph nodes are eligible.
  • Ability to receive MRI-guided radiotherapy.
  • Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy.
  • Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

Exclusion Criteria:

  • Prior history of receiving pelvic radiotherapy.
  • Patient with inflammatory bowel disease.
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of ultra-hypofractionated radiotherapy.
  • History of bladder neck or urethral stricture.

View trial on ClinicalTrials.gov