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

Completed

Conditions: Prostate cancer, high-dose-rate (HDR) brachytherapy, radiorecurrent disease.

Registration Number: NL-OMON27850

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: one

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Age >18 years;
-Biopsy proven local recurrence;
-Biopsy proven recurrence at least 2 years after primary radiotherapy treatment (low-dose-rate brachytherapy 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 PSMA/choline PET scan within anatomical prostate borders (no extracapsular growth or metastases);
-Karnofsky score >70;
-Written informed consent;
-Fit for anaesthesia.

Exclusion Criteria

-Distant metastases;
-Severe toxicity from 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;
-Prior prostate treatment(s) (like a recent TURP (<6 months before focal salvage HDR treatment), HIFU, cryosurgery), except for radiotherapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the occurrence of gastrointestinal and/or genitourinary toxicity after focal salvage HDR-BT for locally recurrent prostate cancer.

Secondary Outcome Measures

Name	Time	Method
-To determine the technical feasibility of MRI guided focal HDR-BT as salvage treatment for locally recurrent prostate cancer;<br>-Quality of life;<br>-Biochemical disease free survival (as defined by Phoenix criterium nadir+2)<br>