Status:
ACTIVE_NOT_RECRUITING
Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Viewray Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18-90 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5 treatments (2 weeks) for ...
Detailed Description
The standard treatment for most patients with biochemical recurrence after radical prostatectomy is salvage radiotherapy. Salvage radiotherapy delays the need for chronic, non-curative treatment, such...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04422132
Start Date
September 24 2020
End Date
December 31 2028
Last Update
August 14 2025
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10065