Two-fraction Ultra-hypofractionated Radiotherapy with Focal Boost for low- and intermediate risk, localized prostate cancer (TURBO):phase II, randomized controlled clinical trial

Phase 2

Recruiting

Conditions: prostate adenocarcinoma
prostate cancer
10036958
10027656
10018188

Registration Number: NL-OMON56580

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

• Age >=18 years
• Histopathological confirmation of prostate adenocarcinoma requiring radical
treatment
• Intraprostatic tumor visible and delineable on diagnostic imaging
• EAU intermediate risk prostate cancer
o PSA < 20 ng/ml
o Gleason score <= 7
o cT1c-cT2b/iT3a (non-bulky, < 20mm)
• Written informed consent
• Informed consent to share medical data and fill out quality of life
questionnaires in the MOMENTUM study.

Exclusion Criteria

• Contraindication to MRI (e.g., pacemaker)
• IPSS 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 (e.g.,
total hip replacement)
• Previous radical prostatectomy
• Previous pelvic radiotherapy
• Previous invasive malignancy within the last 5 years, excluding basal cell
carcinoma of the skin

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>difference in proportion of participants with acute (within 12 weeks after<br /><br>start radiotherapy) CTCAE grade 2 or higher genitourinary toxicity</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To assess physician reported toxicity (CTCAE) other than acute GU toxicity<br /><br>• To assess patient reported outcome measures (PROMs), using the following<br /><br>validated instruments:<br /><br>o EORTC-QLQ-C30 (general quality of life for patients who undergo/underwent<br /><br>oncological treatment)<br /><br>o EQ-5D (cost-effectiveness and general QoL)<br /><br>o EORTC-QLQ-PR25 (prostate-related quality of life after oncological therapy)<br /><br>• To assess biochemical progression free survival and time to relapse, through<br /><br>evaluation of PSA control and kinetics.</p><br>