Prostate cancer, brachytherapy, robotic device
Conditions
Interventions
Single-needle insertion into the prostate by an MR-compatible robotic device, prior to the conventional manual focal salvage high-dose-rate brachytherapy procedure.
Sponsors
University Medical Center Utrecht (UMCU)
Eligibility
Inclusion criteria
Inclusion criteria: - Age at least 18 years; - Biochemical recurrence according to the RTOG-ASTRO Phoenix definition (PSA >2 ng/ml above nadir) at least 2 years after primary treatment; - Stage T3b tumour or lower; - Recurrent lesion visible on 68Ga-PSMA-PET-CT and at least 1 sequence of the mp-MRI (T2 weighted (T2W), DCE or DWI); - Karnofsky score at least 70; - Prior prostate cancer treatment with standard external beam radiation therapy (EBRT), for which fiducial gold markers were placed in the prostate; - Tumour location technically feasible for robotic needle placement as determined on diagnostic MRI scan and PET-CT scan; - Written informed consent.
Exclusion criteria
Exclusion criteria: - Metastatic disease; - Other prostate cancer treatments in the past (HIFU or cryosurgery), except for radiotherapy; - Trans-urethral resection of the prostate (TURP) within the past 6 months; - Prior radiotherapy for a malignancy in the pelvic area, other than prostate cancer; - Continuously required anticoagulant administration, except for platelet aggregation inhibitors (for example Ascal/Persantin); - Hypofractionated EBRT as primary prostate cancer treatment; - Less than 3 gold markers visible in the prostate on the pre-treatment MRI-scan; - Physical inability to spread the legs sufficiently for positioning in the leg supports; - Contra-indications for MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the technical feasibility of using a robotic needle-implant device, which will be determined by the needle-to-tumour-target distance. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Geometric accuracy of the brachytherapy needle position in the prostate compared to the planned position (quantified by needle-to-geometric-target (NTG) distance; - Deformation of the prostate during and after needle insertion; - Duration of the robotic needle insertion procedure; - Toxicity related to treatment. | — |
Contacts
Public ContactJ.R.N. Voort van Zyp, van der
UMC Utrecht, Department of Radiotherapy
Outcome results
None listed