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

Recruiting

Conditions: prostate cancer
recurrent prostate carcinoma
10038597
10025506

Registration Number: NL-OMON47701

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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 brachytherapie or external beam radiation therapy)
- Limited and non-aggressive tumor presentation at time of salvage (Prostate
Spedific Antigen (PSA) at time of salvage <10)
- Prostate Specific Antigen (PSA) doubling time more than 12 months
- Acceptable toxicity of primary radiation treatment (International Prostate
Symptom Score (IPSS)<15)
- Tumour location technically feasible for brachytherapy
- Tumour on MRI and PSMA-PET scan within anatomical prostate borders (no
extracapsular growth or metastasis)
- Karnofsky score >=70
- Written informed consent
- Fit for spinal anaesthesia

Exclusion Criteria

- Distant metastasis
- Severe toxicity during primary radiation treatment (International Prostate
Symptom Score (IPSS)>15)
- Patients who meet exclusion criteria for MRI following the protocol of the
radiology department of the UMC Utrecht
- Anticoagulant administration continuously required, except for Ascal
- Discongruence between prostate biopsies and contrast MR imaging
- No prior prostate cancer 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
<p>Incidence of grade>=3 gastro-intestinal and/or urogenital toxicity after MRI<br /><br>guided focal salvage therapy for locally recurrent prostate cancer. Toxicity<br /><br>will be determined by the Common Terminology Criteria for Adverse Events<br /><br>(CTCAE) version 4.0 (National Cancer Institute). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine the technical feasibility of MRI guided focal high-dose rate<br /><br>brachytherapy as salvage therapy for locally recurrent prostate cancer<br /><br>- Quality of life<br /><br>- Biochemical disease free survival (Phoenix criteria)</p><br>