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


- candidate number14195
- NTR NumberNTR3790
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jan-2013
- Secondary IDsNL41443.041.12 / 12-402; CCMO / METC
- Public TitleFeasibility of MRI guided focal high-dose-rate brachytherapy for localized prostate cancer (Plaatselijke inwendige bestraling voor patiŽnten met prostaatkanker).
- Scientific TitleFeasibility of MRI guided focal high-dose-rate brachytherapy for localized prostate cancer.
- ACRONYM
- hypothesisFavourable risk prostate cancer is common in men in developed countries. These cancers are often biologically indolent and therefore not clinically significant. However, no consensus has been reached with regard to the best approach of these tumours. Nowadays, low-dose-rate (LDR) brachytherapy is often implemented for patients with favourable risk prostate cancer, since it is a minimally invasive procedure. Still, grade 3 toxicity remains a concern in 5-34% of all series. Studies regarding high-dose-rate (HDR) brachytherapy (BT) as monotherapeutic treatment of the entire prostate, show promising results regarding toxicity of bladder and rectum. Nevertheless, severe toxicity is still present. To reduce toxicity in patients with localized prostate cancer, focal treatment is warranted. This can be achieved with MRI guided high-dose-rate brachytherapy. In the past, focal treatment has not been explored since determination of exact tumour location was not precise. Currently, our radiotherapy centre is the only department worldwide with a MRI HDR brachytherapy facility, allowing MRI guided catheter placement and treatment. With this facility, catheter placement can be done far more accurately, which makes focal treatment possible. By using focal treatment, less toxicity is expected. In earlier studies, a dose of 19 Gy to the entire prostate was shown to be feasible. Therefore we expect that focal treatment of 19 Gy to the tumour focus will be of benefit to the patient with localized prostate cancer. In case of recurrent (biochemical) disease, suitable re-treatment will be performed.
- Healt Condition(s) or Problem(s) studiedBrachytherapy, MRI-guided, High-dose-rate, Localized prostate cancer
- Inclusion criteria1. Age ≥ 65 years;
2. Patients with prostate cancer, T stage ≤ T2, 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 21-jan-2013
- planned closingdate21-jan-2017
- Target number of participants30
- InterventionsHigh-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 be performed by insertion of catheters under ultrasound guidance. Under MR guidance, cathether placement will be adjusted, according to the exact tumour position.
- Primary outcomeIncidence of gastro-intestinal and/or urogenital toxicity, aiming for less than 5% grade ≥ 3 toxicity.
- Secondary outcome1. 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.
- TimepointsThe treatment will include one high-dose-rate treatment of 19 Gy. Questionnaires will be used to assess toxicity and quality of life (before treatment, one month after treatment, every 3 months the first year, every 6 months the second year, thereafter once a year). For assessment of biochemical recurrence, PSA monitoring will be performed during each visit.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M. Maenhout
- CONTACT for SCIENTIFIC QUERIES J.R.N. Voort van Zyp, van der
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Department of Radiotherapy
- PublicationsN/A
- Brief summaryFavourable risk prostate cancer is common in men in developed countries. These cancers are often biologically indolent and therefore not clinically significant. However, no consensus has been reached with regard to the best approach of these tumours. Nowadays, low-dose-rate (LDR) brachytherapy is often implemented for patients with favourable risk prostate cancer, since it is a minimally invasive procedure. Still, grade 3 toxicity remains a concern in 5-34% of all series. Studies regarding high-dose-rate (HDR) brachytherapy (BT) as monotherapeutic treatment of the entire prostate, show promising results regarding toxicity of bladder and rectum. Nevertheless, severe toxicity is still present. To reduce toxicity in patients with localized prostate cancer, focal treatment is warranted. This can be achieved with MRI guided high-dose-rate brachytherapy. In the past, focal treatment has not been explored since determination of exact tumour location was not precise. Currently, our radiotherapy centre is the only department worldwide with a MRI HDR brachytherapy facility, allowing MRI guided catheter placement and treatment. With this facility, catheter placement can be done far more accurately, which makes focal treatment possible. By using focal treatment, less toxicity is expected. In earlier studies, a dose of 19 Gy to the entire prostate was shown to be feasible. Therefore we believe that focal treatment of 19 Gy to the tumour focus will be of benefit to the patient with localized prostate cancer. In case of recurrent (biochemical) disease, suitable re-treatment will be performed.

Country of recruitment: The Netherlands.
- Main changes (audit trail)
- RECORD11-jan-2013 - 20-jan-2013


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