PRostatE Cancer MRI guided focal SalvagE high-dose-rate brachytherapy

Phase 2

Recruiting

Conditions: prostate cancer
10038597
Recurrent prostate carcinoma
10036958
10025506

Registration Number: NL-OMON48560

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 88

Inclusion Criteria

- Age >=18 years;
- Recurrence >=2 years after primary radiotherapy treatment (low-dose-rate
brachytherapy of external beam radiation therapy);
- Prostate Specific Antigen (PSA) at time of salvage <=20 ng/ml;
- Prostate Specific Antigen (PSA) doubling time >=9 months;
- Stage <=T3b tumor (extra prostatic extension into the seminal vesicle(s));
- Acceptable toxicity of primary radiation treatment (International Prostate
Symptom Score (IPSS)<15);
- Concordance between PSMA-PET/CT and mp-MRI;
- Tumor location technically feasible for brachytherapy;
- Karnofsky score >=70;
- Written informed consent;
- Fit for spinal anesthesia.

Exclusion Criteria

- Distant metastases;
- Previous pelvic radiotherapy for another malignancy;
- Prior prostate treatment(s) like a recent transurethral resection of the
prostate (TURP) (<6 months before focal salvage HDR treatment), HIFU or
cryosurgery, except for radiotherapy;
- Contraindications for MRI;
- Severe toxicity from primary radiation treatment (IPSS >15);
- Anticoagulant administration continuously required, except for platelet
aggregation inhibitors (for example Ascal/Persantin).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The incidence of gastrointestinal and/or genitourinary toxicity, which will be<br /><br>determined by the Common Terminology Criteria for Adverse Events (CTCAE)<br /><br>version 4.0.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- QoL assessment by questionnaires (RAND-36, EORTC QLQ-PR-25, EORTC QLQ-C30,<br /><br>IPSS, IIEF-5);<br /><br>- PSA-monitoring for evaluation of biochemical disease free survival;<br /><br>- Dose restrictions analysis by relating dosage to toxicity to prevent/reduce<br /><br>toxicity;<br /><br>- Evaluation of catheter shifts during focal salvage HDR-BT;<br /><br>- Prediction-modeling for the determination of predictive factors for tumor<br /><br>control, to further optimize patient selection.</p><br>