Status:
RECRUITING
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer
Lead Sponsor:
UMC Utrecht
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 radiot...
Detailed Description
Rationale: Hypofractionation in prostate cancer radiotherapy has already led to a drastic reduction in fractionation scheme from 35 fractions to the now standard 5 fractions for patients with intermed...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Histopathological confirmation of prostate adenocarcinoma requiring radical treatment
- European Association of Urology (EAU) intermediate risk prostate cancer, defined as Prostate Specific Antigen (PSA) level of \< 20 ng/ml, Gleason score ≤ 7, cT1c-cT2b/iT3a (non-bulky, \< 20mm)
- Written informed consent
- Ability and willingness to comply with Patient Reported Outcome Measure (PROM) questionnaires schedule throughout the study
- Inclusion in the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM)
Exclusion
- Contraindications to MRI
- International Prostate Symptom Score (IPSS) of 15 or higher
- Prostate volume \> 80 cc
- Comorbidities which predispose to significant toxicity (e.g., inflammatory bowel disease)
- Metal pelvic implants which cause artefact on MR-imaging sequences
- Previous radical prostatectomy
- Previous pelvic radiotherapy
- Previous invasive malignancy within the last 5 years, excluding basal cell carcinoma of the skin
Key Trial Info
Start Date :
March 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06518226
Start Date
March 28 2024
End Date
February 1 2031
Last Update
July 24 2024
Active Locations (1)
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1
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX