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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55755

Enrollment

Registered

2018-05-24

Start date

2019-07-02

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer prostate carcinoma

Interventions

All patients are treated with brachytherapy either on the whole gland or hemigland. The treatments are performed with a permanent implantation with I-125 sources or a temporary implantation with HDR

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 =12 7. Sexually active 8. International Prostate Symptom Score (IPSS) 18 years 11. Written informed consent

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)