NL-OMON55755CompletedNot Applicable
Randomized trial for the evaluation of erectile dysfunction after whole or partial gland prostate brachytherapy: POWER (Partial or Whole gland for Erections) - POWER
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 65
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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)
Investigators
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