Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy.
- Who it may be relevant to
- Registry conditions: Post-Operative Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY
Overview
This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
Interventions
- Radiation Radiotherapy
Non-institutional-standard radiotherapy
Primary outcome measures
- Rates of Acute Toxicity [Time frame: 2 years]
Secondary outcome measures (5)
- Rates of Acute and Late Toxicity [Time frame: 2 years]
- Quality of Life Outcomes [Time frame: 2 years]
- Quality of Life Outcomes [Time frame: 2 years]
- Biochemical disease-free survival [Time frame: 2 years]
- Disease Control Rate [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Age >/= 18 years
- Able to provide informed consent
- Histologic diagnosis of prostate adenocarcinoma
- ECOG performance status 0-1
- Previous radical prostatectomy > 6 months prior to radiotherapy start date
- Planned to receive post-operative radiation
Exclusion criteria
- Prior pelvic radiotherapy
- Contraindications to radiotherapy
- Confirmed metastases (if scan has been done for clinical care)
- Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- London Health Sciences Centre — London
- University Health Network - Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT06409910 · 23-5813