Prospective multi-centre study of low-dose Iodine125 (I-125) prostate brachytherapy performed after transurethral resection. PROBATE study

Phase 2

Completed

• Conditions: Prostate cancer; prostate malignancy; 10038588

• Registration Number: NL-OMON37110
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

-Histologically proven prostate cancer (adenocarcinoma) of low or intermediate risk following the D*Amico classification.
-Prostate volume < 50 cc
-History of TransUrethral Resection of the prostate (TURp), performed at least 3 months before the brachytherapy procedure.
-Rim of prostate tissue of at least 1 cm around the post-TURp urethral defect at thepostero-lateral sides of the prostate
-Absence of significant TURP-induced urinary incontinence
- IPSS <15

Exclusion Criteria

-Locally advanced (stage T3 or T4 , or metastatic (stage N+ or M+) prostate cancer
-High grade tumours defined by Gleason score 8 or above
-Co-morbidity which would exclude the patient from a transperineal implant procedure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acute and late urinary toxicity defined by IPSS and CTCAEv4 </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Gastro-intestinal and sexual function<br /><br>- Biochemical disease free survival (Phoenix-definition).<br /><br>- Incidence of seed loss at 1month and 6 months after implant</p><br>