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Feasibility of MRI guided focal high-dose-rate brachytherapy for localized prostate cancer (Plaatselijke inwendige bestraling voor patiënten met prostaatkanker).

Completed
Conditions
High-dose-rate brachytherapyMRI-guidedLocalized prostate cancer
Registration Number
NL-OMON21756
Lead Sponsor
niversity Medical Center Utrecht
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

1. Age =65 years;
2. Patients with prostate cancer, T stage =T2c, Gleason =7, Prostate Specific Antigen (PSA) <10 ng/ml;
3. Tumour location technically feasible for brachytherapy;
4. Karnofski score =70;
5. Written informed consent;
6. Fit for spinal anaesthesia.

Exclusion Criteria

1. Previous pelvic radiotherapy for another malignancy;
2. Previous surgery or transurethral resection of the prostate;
3. Prostate cancer recurrence;
4. Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht;
5. International Prostate Symptom Score (IPSS) >15;
6. Anticoagulant administration continuously required;
7. Discongruence between prostate biopsies and MR imaging.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of gastro-intestinal and/or urogenital toxicity, aiming for less than 5% grade =3 toxicity.
Secondary Outcome Measures
NameTimeMethod
1. To determine the technical feasibility of MRI guided focal high-dose rate brachytherapy for localized prostate cancer;<br>2. Quality of life;<br>3. Biochemical disease-free survival.
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