Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer

Official record

Identifier

NCT04197141

Recruiting locations

country

Canada

Interventions studied

Conventionally-fractionated WPRTHypofractionated WPRT

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Target enrolment

58 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Active, not recruiting

First posted

Dec 12, 2019

Last updated on the registry

Oct 1, 2026

Age

18 Years

Sex

MALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Age 18 or older
* Study Informed Consent provided
* Pathologically proven diagnosis of prostatic adenocarcinoma
* Unfavorable intermediate risk \[with greater than 15% chance of node involvement based on Memorial Sloan Kettering Cancer Center (MSKCC) nomogram https://www.mskcc.org/nomograms/prostate\] or high or very-high-risk prostate cancer based on National Comprehensive Cancer Network (NCCN) classification \[Prostatic Specific Antigen (PSA) \> 20 ng/mL or clinical cT3a or cT3b or Gleason 8-10\]
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* No prior history of pelvic irradiation, brachytherapy, cryosurgery, High-Intensity Focused Ultrasound (HIFU), Transurethral Resection of the Prostate (TURP) or radical prostatectomy

Exclusion Criteria:

* Presence of nodal or distant metastasis, as confirmed by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) of the chest/abdomen/pelvis and bone scan within 45 days of randomization
* Plan for adjuvant docetaxel post-radiotherapy
* Serious medical comorbidities or other contraindications to HDR-BT
* Presence of inflammatory bowel disease
* Presence of connective tissue disease
* Medically unfit for general anesthesia
* Unable or unwilling to complete questionnaires

Indexed under

Prostate Cancer