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Feasibility of MRI-guided focal salvage high-dose-rate brachytherapy for locally recurrent prostate cancer


- candidate number25418
- NTR NumberNTR6123
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-okt-2016
- Secondary IDs12-622 
- Public TitleFeasibility of MRI-guided focal salvage high-dose-rate brachytherapy for locally recurrent prostate cancer
- Scientific TitleFeasibility of MRI-guided focal salvage high-dose-rate brachytherapy for locally recurrent prostate cancer
- ACRONYM
- hypothesisThe purpose of this study is to evaluate toxicity and feasibility of MRI-guided focal salvage high-dose-rate brachytherapy (HDR-BT) in patients with locally recurrent prostate cancer. In comparison with whole-gland salvage techniques, focal salvage is expected to reduce toxicity, while maintaining cancer control.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Brachytherapy
- Inclusion criteria- Age ≥18 years.
- Biopsy proven local recurrence
- Biopsy proven recurrence at least 2 years after primary radiotherapy treatment (low-dose-rate brachytherapie or external beam radiation therapy)
- Limited and non-aggressive tumor presentation at time of salvage (PSA at time of salvage <10)
- PSA doubling time more than 12 months
- Acceptable toxicity of primary radiation treatment (IPSS<15)
- Tumour location technically feasible for brachytherapy
- Tumour on MRI and PSMAcholine PET scan within anatomical prostate borders (no extracapsular growth or metastasis)
- Karnofsky score ≥70
- Written informed consent
- Fit for anaesthesia
- Exclusion criteria- Distant metastasis
- Severe toxicity during primary radiation treatment (IPSS>15)
- Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht (see appendix)
- Anticoagulant administration continuously required, except for Ascal
- Discongruence between prostate biopsies and contrast MR imaging
- No prior prostate treatment(s) (like a recent TURP (<6 months before focal salvage HDR treatment), HIFU, cryosurgery), except for radiotherapy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 11-jul-2013
- planned closingdate1-jan-2021
- Target number of participants30
- InterventionsSingle fraction HDR treatment to a dose of 19 Gray
- Primary outcomeTo investigate the occurrence of gastrointestinal and/or urogenital toxicity after focal salvage HDR-BT for locally recurrent prostate cancer
- Secondary outcome- To determine the technical feasibility of MRI guided focal high-dose rate brachytherapy as salvage therapy for locally recurrent prostate cancer
- Quality of life
- Biochemical disease free survival (Phoenix criteria)
- Timepoints4 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J.R.N. Voort van Zyp, van der
- CONTACT for SCIENTIFIC QUERIESMD, PhD M. Peters
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsNone
- Brief summaryProstate cancer recurrence after primary treatment is common, despite improvements in primary curative treatment modalities. Various salvage treatment modalities, like radical prostatectomy, low-dose-rate brachytherapy, external beam radiotherapy, HIFU (high intensity focused ultrasound) and cryosurgery have been investigated. However, because of high failure and high toxicity rates, these treatment modalities remain unpopular. High failure rates can be reduced by excluding patients with a high risk for early distant metastasis. In these patients, local salvage treatment will not be of any benefit. High toxicity rates can be explained by the fact that salvage therapy is often performed on the entire prostate, which induces accumulation of a high irradiation dose on normal tissues. To reduce the burden of a high radiation dose on normal tissues, focal therapy is warranted. This can be achieved with MRI-guided focal salvage HDR-BT (high-dose-rate brachytherapy). In the past, focal salvage treatment has not frequently been explored, since determination of exact tumour location was not precise. Currently, our radiotherapy centre has a MRI HDR-BT facility, allowing MRI guided catheter placement and treatment. With this facility, catheter placement can be done far more accurately, which makes focal treatment possible. Due to the steep dose fall-off, low radiation doses will be expected in the surrounding healthy tissues. Therefore, less toxicity to the organs at risk is expected. In earlier studies, salvage HDR-BT has been shown to be feasible. Moreover, results regarding toxicity are promising. Therefore, we expect that MRI guided salvage treatment by using HDR-BT will be of benefit in patients with recurrent prostate cancer.
- Main changes (audit trail)
- RECORD17-okt-2016 - 3-jan-2017


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