RObotic mri-guided high dose rate Brachytherapy Needle implantation in the proState - a proof of concept study

Completed

• Conditions: Prostate cancer; prostatic carcinoma; 10038597; 10036958; 10025506

• Registration Number: NL-OMON55715
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

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 <=T3b tumour;
o Recurrent lesion visible on 68Ga-PSMA-PET-CT and at least 1 sequence of
the mp-MRI (T2 weighted (T2 weighted (T2W), DCE or DWI);
o Karnofsky score >=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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified