Actively Recruiting
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer
Led by UMC Utrecht · Updated on 2024-07-24
160
Participants Needed
1
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. The main question it aims to answer are: \- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) side effects? Participants in the intervention arm will receive two fractions of radiotherapy, in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 13.5 Gray (Gy), over the course of 8 days. Those in the control arm will receive five fractions of radiotherapy of 7.25 Gy each to the prostate, without a boost to the tumor, over the course of 16-18 days.
CONDITIONS
Official Title
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histopathological confirmation of prostate adenocarcinoma requiring radical treatment
- Intermediate risk prostate cancer defined as PSA level less than 20 ng/ml, Gleason score 7 or lower, and clinical stage cT1c-cT2b/iT3a (non-bulky, less than 20 mm)
- Written informed consent provided
- Ability and willingness to complete patient-reported outcome questionnaires during the study
- Enrollment in the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM)
You will not qualify if you...
- Contraindications to MRI
- International Prostate Symptom Score (IPSS) of 15 or higher
- Prostate volume greater than 80 cc
- Comorbidities that increase risk of significant toxicity, such as inflammatory bowel disease
- Presence of metal pelvic implants causing artifacts on MRI scans
- Previous radical prostatectomy
- Previous pelvic radiotherapy
- Previous invasive cancer within the last 5 years, except basal cell carcinoma of the skin
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
Research Team
T
Tariq A. Lalmahomed, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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