Randomized trial for the evaluation of erectile dysfunction after whole or partial gland prostate brachytherapy: POWER (Partial or Whole gland for Erections)

Completed

Conditions: prostate carcinoma
10038597
prostate cancer

Registration Number: NL-OMON55755

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

1. Histologically adenocarcinoma on systematic prostate biopsies and targeted
biopsies after mpMRI
2. Unilateral tumor confirmed by histology.
3. Clinical stage T1c-T2b
4. Gleason score 3 + 3 with >=30% tumor of all taken cores (ISUP Grade Group 1),
Gleason score 3 + 4 (ISUP Grade Group 2), and Gleason 4 + 3 (ISUP Grade Group
3)
5. PSA <=15 ng/ml and Gleason 7 (Grade Group 2-3) or PSA <=20 ng/mL and Gleason 6
(Grade Group 1)
6. Baseline IIEF-5 score >=12
7. Sexually active
8. International Prostate Symptom Score (IPSS) <= 20
9. WHO performance score <= 2
10. Age > 18 years
11. Written informed consent

Exclusion Criteria

1. Contraindication for mpMRI
2. Bleeding disorder preventing invasive treatment as a prostate implantation
3. Not able to stop coumarine derivates
4. Active urinary tract infection
5. Any history of bladder neck stricture
6. Comorbidity preventing general or spinal anesthesia
7. Any history of inflammatory bowel disease
8. Prior or concurrent malignancy except for non-melanoma skin cancer or other
malignancy from which the patient has been cured for at least 5 years
9. Life expectancy of < 5 years
10. Prostate calcifications greater than 5 mm
11. Chemotherapy for prostate cancer
12. Hormonal therapy for prostate cancer within 1 year prior to procedure
13. Previous radiation to pelvis
14. Recurrent prostate cancer
15. Transurethral resection of the prostate or urethral stent
16. Prior major rectal surgery (except haemorrhoids)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is deterioration of erectile function by assessment of the<br /><br>IIEF-5 score. A drop of at least 5 points compared to baseline<br /><br>value or a need to start with a phosphodiesterase 5 inhibitor (PDE5 inhibitor)<br /><br>(or other medical interventions to improve erections) at last follow-up is<br /><br>considered as an event.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are:<br /><br>- To assess differences in urinary and rectal late effects between whole gland<br /><br>and partial prostate brachytherapy.<br /><br>- To assess differences in post-procedural quality of life measured by EORTC<br /><br>QLQC30 and QLQ-PR25 questionnaire.<br /><br>- To assess the local oncological efficacy as measured by the proportion of men<br /><br>who are free of local prostate cancer in the two different groups. This will be<br /><br>examined by standardized 12 core prostate biopsies and mpMRI.</p><br>