Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833426
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2021-02-05
Brief Title:
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Sponsor:
Canisius-Wilhelmina Hospital
Organization:
Canisius-Wilhelmina Hospital
Study Overview
Official Title:
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENFORCE
Brief Summary:
Sexual dysfunction is a common side effect of radical prostatectomy RP and has a significant negative impact on quality of life With age the testosterone level in men declines around 30 of men over 70 years of age meet the criteria of testosterone deficiency TD The negative impact of both TD and RP on sexual performance are likely to add up The aim of this study is to assess the efficacy and safety of testosterone replacement therapy TRT on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer PCa
Detailed Description:
Rationale Radical prostatectomy RP is currently the most common treatment for non-metastatic prostate cancer PCa Two frequent side effects of this procedure are urinary incontinence and erectile dysfunction both having a significant negative impact on quality of life
Additionally it is known that with age the testosterone level in men declines This does not lead to symptoms in all men asymptomatic testosterone deficiency Both testosterone deficiency TD and radical prostatectomy are well-established to have a significant negative impact on sexual performance and are likely to add up in patients with a low testosterone following RP
Objective The aim of this study is to assess the effect of testosterone replacement therapy TRT on functional and oncological outcomes in testosterone deficient men following RP for PCa
Study design This study is a phase 3 prospective randomized placebo-controlled single-blind clinical trial Study population All men over 18 years old diagnosed with non-metastatic prostate cancer who are scheduled for RP within three months as primary treatment can be prescreened for inclusion Prior to the RP serum testosterone will be determined Subsequently within six weeks after the RP serum testosterone will be determined again and patients will be screened for inclusion If necessary a third measurement of testosterone will be done Eligible patients meet the criteria for TD and other inclusion criteria Intervention Patients will be randomized for testosterone replacement therapy TRT or placebo as a daily administered topical gel starting within 8 weeks after RP Patients will receive TRT or placebo for one year following RP and will be monitored for another year for functional outcomes and for four more years to establish 5-year biochemical recurrence BCR free survival
Main study parametersendpoints
The primary study endpoint is a clinically relevant 12 points or more difference in the EPIC-26 domain for sexual functioning 12 months after RP in favor of testosterone deficient men receiving TRT compared with testosterone deficient men receiving placebo Secondary endpoints include urinary incontinence score hormonal functioning score and BCR-free survival Nature and extent of the burden and risks associated with participation benefit and group relatedness The number of visits and blood drawings are equal to standard of care follow-up after RP with the exception of two or three extra blood samples at the first prescreening visit and within six weeks following RP We ask patients to remain with their hospital for 24 months after RP for follow-up and to complete online questionnaires for the given visits The five-year biochemical recurrence BCR free survival will be obtained through patients medical records and if insufficient through the Dutch Cancer Registry NKR Patients who receive TRT or placebo can experience local side-effects such as itching rash andor irritation at the site of application In addition patients who receive TRT can experience systemic sideeffects are gain of weight hot flashes acne and an increase in red blood count level Furthermore TRT might improve sexual functioning urinary continence hormonal functioning and BCR-free survival but this is not certain and is subject of research in this study
Additionally it is known that with age the testosterone level in men declines This does not lead to symptoms in all men asymptomatic testosterone deficiency Both testosterone deficiency TD and radical prostatectomy are well-established to have a significant negative impact on sexual performance and are likely to add up in patients with a low testosterone following RP
Objective The aim of this study is to assess the effect of testosterone replacement therapy TRT on functional and oncological outcomes in testosterone deficient men following RP for PCa
Study design This study is a phase 3 prospective randomized placebo-controlled single-blind clinical trial Study population All men over 18 years old diagnosed with non-metastatic prostate cancer who are scheduled for RP within three months as primary treatment can be prescreened for inclusion Prior to the RP serum testosterone will be determined Subsequently within six weeks after the RP serum testosterone will be determined again and patients will be screened for inclusion If necessary a third measurement of testosterone will be done Eligible patients meet the criteria for TD and other inclusion criteria Intervention Patients will be randomized for testosterone replacement therapy TRT or placebo as a daily administered topical gel starting within 8 weeks after RP Patients will receive TRT or placebo for one year following RP and will be monitored for another year for functional outcomes and for four more years to establish 5-year biochemical recurrence BCR free survival
Main study parametersendpoints
The primary study endpoint is a clinically relevant 12 points or more difference in the EPIC-26 domain for sexual functioning 12 months after RP in favor of testosterone deficient men receiving TRT compared with testosterone deficient men receiving placebo Secondary endpoints include urinary incontinence score hormonal functioning score and BCR-free survival Nature and extent of the burden and risks associated with participation benefit and group relatedness The number of visits and blood drawings are equal to standard of care follow-up after RP with the exception of two or three extra blood samples at the first prescreening visit and within six weeks following RP We ask patients to remain with their hospital for 24 months after RP for follow-up and to complete online questionnaires for the given visits The five-year biochemical recurrence BCR free survival will be obtained through patients medical records and if insufficient through the Dutch Cancer Registry NKR Patients who receive TRT or placebo can experience local side-effects such as itching rash andor irritation at the site of application In addition patients who receive TRT can experience systemic sideeffects are gain of weight hot flashes acne and an increase in red blood count level Furthermore TRT might improve sexual functioning urinary continence hormonal functioning and BCR-free survival but this is not certain and is subject of research in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-6874 | OTHER | CMO Arnhem-Nijmegen | None |
| 2020-003012-27 | EUDRACT_NUMBER | None | None |