Prostate cancer prostatic carcinoma
Conditions
Interventions
Single-needle insertion into the prostate by an MR-compatible robotic device,
prior to the conventional manual focal salvage HDR-BT procedure.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - All eligibility criteria for focal salvage high-dose-rate brachytherapy (HDR-BT) as currently followed by the department of Radiotherapy at the UMCU: o Age >=18 years; o Local recurrence >2 years after primary treatment. o Stage =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: - Any contra-indications for focal salvage HDR-BT as currently followed by the department of Radiotherapy at the UMCU: o Metastatic disease; o Other prostate cancer treatments in the past (HIFU or cryosurgery), except for radiotherapy; o Trans-urethral resection of the prostate (TURP) within the past 6 months; o Prior radiotherapy for a malignancy in the pelvic area, other than prostate cancer; o 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 |
|---|---|
| The primary endpoint is the technical feasibility of using the robotic needle-implant device, which will be determined by the needle-to-tumour-target distance. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine the geometric accuracy of the brachytherapy needle position in the prostate compared to the planned position (quantified by needle-to-geometric-target (NTG) distance; - To quantify the deformation of the prostate during and after needle insertion; - To determine the duration of a robotic needle insertion procedure; - To assess toxicity related to treatment. | — |
Countries
Netherlands
Outcome results
None listed