Robot-gestuurde plaatselijke inwendige bestraling voor de behandeling van patiënten met teruggekeerde prostaatkanker.
- Conditions
- Prostate cancer, brachytherapy, robotic device
- Registration Number
- NL-OMON26571
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the technical feasibility of using a robotic needle-implant device, which will be determined by the needle-to-tumour-target distance.
- Secondary Outcome Measures
Name Time Method - Geometric accuracy of the brachytherapy needle position in the prostate compared to the planned position (quantified by needle-to-geometric-target (NTG) distance;<br>- Deformation of the prostate during and after needle insertion;<br>- Duration of the robotic needle insertion procedure;<br>- Toxicity related to treatment.