Feasibility of MRI guided focal high-dose-rate brachytherapy for localized prostate cancer

Recruiting

• Conditions: localized prostate carcinoma; prostate cancer; 10038597; 10025506

• Registration Number: NL-OMON47892
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Age >= 65 years
- Patients with prostate cancer, T stage < T3, Gleason <=7, Prostate Specific
Antigen (PSA) <10 ng/ml
- Tumour location technically feasible for brachytherapy
- Karnofski score >=70
- Written informed consent
- Fit for spinal anaesthesia

Exclusion Criteria

- Previous pelvic radiotherapy for another malignancy
- Previous surgery or transurethral resection of the prostate
- Prostate cancer recurrence
- Patients who meet exclusion criteria for MRI following the protocol of the
radiology department of the UMC Utrecht
- International Prostate Symptom Score (IPSS) >15
- Anticoagulant administration continuously required, except for platelet
aggregation inhibitors (for example Ascal/Persantin)
- Discongruence between prostate biopsies and MR imaging

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of gastro-intestinal and/or urogenital toxicity, aiming for less than<br /><br>5% grade >=3 toxicity will be determined by the Common Toxicity Criteria for<br /><br>Adverse Events (CTCAE) version 4.0 (National Cancer Institute).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine the technical feasibility of MRI guided focal high-dose rate<br /><br>brachytherapy for localized prostate cancer<br /><br>- Quality of life<br /><br>- Biochemical disease free survival</p><br>