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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21756
Enrollment
30
Registered
2013-01-11
Start date
2013-01-21
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-dose-rate brachytherapy MRI-guided Localized prostate cancer

Interventions

High-dose-rate brachytherapy will be performed for patients with low to intermediate risk prostate carcinoma. The treatment will include a single fraction of 19 Gy. High-dose-rate brachytherapy will b

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Incidence of gastro-intestinal and/or urogenital toxicity, aiming for less than 5% grade =3 toxicity.

Secondary

MeasureTime frame
1. To determine the technical feasibility of MRI guided focal high-dose rate brachytherapy for localized prostate cancer; 2. Quality of life; 3. Biochemical disease-free survival.

Contacts

Public ContactJ.R.N. van der Voort van Zyp

UMC Utrecht, Department of Radiotherapy

J.R.N.vanderVoortvanZyp@umcutrecht.nl+31 (0)88 7558800

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)