Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Canisius Wilhelmina Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

14 Dec 2022 → ongoing

Decision date (initial)

2024-12-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

KWF subsidie (projectnr 13590 call 2021-01) · Besins Healthcare

External identifiers

EU CT number

2024-511340-29-02

EudraCT number

2020-003012-27

ClinicalTrials.gov

NCT04833426

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP, leads to better outcomes in the domain of sexual functioning 12 months after Radical Prostatectomy (RP)
compared to testosterone deficient men who receive placebo therapy.

Secondary objectives 8

1. Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP leads to better outcomes in the domain of sexual functioning 3 months after Radicale Prostatectomy (RP).
2. Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP leads to better outcomes in the domain of sexual functioning 24 months after RP.
3. Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP leads to better outcomes in the domain of urinary continence 12 months after RP.
4. Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP leads to better outcomes in the domain of urinary continence 24 months after RP.
5. Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP leads to better outcomes in the domain of hormonal functioning 12 months after RP.
6. Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP leads to better outcomes in the domain of hormonal functioning 24 months after RP.
7. Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP leads to better to both a reduction of and longer interval to BCR following RP, at 1, 2 and 5 years after RP.
8. Exploratory objective: gain insight on the effect of RP on serum testosterone levels in both patients with normal pre-operative

Conditions and MedDRA coding

Late-onset hypogonadism

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 16

1. Prescreening eligibility criteria 1. Signed informed consent form 1 (IC)
2. Inclusioncriteria: 2. Signed informed consent form 2 (IC)
3. Inclusioncriteria: 3. Undetectable PSA level at 4-week follow-up
4. Inclusioncriteria: 4. pT2-pT3a on specimen after RP
5. Inclusioncriteria: 5. ISUP 1-3 independent of surgical margin status or ISUP 4-5 with negative surgical margins.
6. Inclusioncriteria: 6. No metastatic lymphnodes in case a pelvic lymphnode dissection has been performed.
7. Inclusioncriteria: 7. No general contra-indications for testosterone
8. Prescreening eligibility criteria 2. Age > 18 years
9. Prescreening eligibility criteria 3. Histologically confirmed prostate cancer
10. Prescreening eligibility criteria 4. Scheduled for radical prostatectomy (RP) as primary treatment with at least one-side nervesparing
11. Prescreening eligibility criteria 5. Non-metastatic disease (cN0M0)
12. Prescreening eligibility criteria 6. Willing to provide two or three (depending on outcome) blood samples to determine testosterone level
13. Prescreening eligibility criteria 7. Willing to use testosterontherapy/placebo by transdermal gel
14. Prescreening eligibility criteria 8. a mimimal sexual functioning of 40 points in the EPIC-26 sexual functioning domain score.
15. Inclusioncriteria: 1. Testosterone deficiency: total testosterone < 8nmol/l OR total testosterone 8-12 nmol/l and free testosterone < 225 pmol/l, measured at two separate occasions and normal or elevated LH.
16. Inclusion criteria 8: At least one-sided nerve-sparing procedure.

Exclusion criteria 9

1. Prescreening exclusion criteria: 1. Any previous treatment for prostate cancer, for example but not limited to: anti-hormonal therapy, radiotherapy, brachytherapy (active surveillance is allowed)
2. Prescreening exclusion criteria: 2. Previous use of testosterontherapy for any reason
3. Prescreening exclusion criteria: 3. History of male breast cancer
4. Prescreening exclusion criteria: 4. History of liver tumor
5. Prescreening exclusion criteria: 5. Uncontrolled hypertension
6. Prescreening exclusion criteria: 6. Allergy for components in the testosterone therapy agent or placebo
7. Prescreening exclusion criteria: 7. Use of vitamin-K antagonists (acenocoumarol or fenprocoumon)
8. Prescreening exclusion criteria: 8. metastases (cN1/M1)
9. Prescreening exclusion criteria: 9. BMI > 30

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main endpoint for this study is the total sexual domain score coming from the EPIC-26 questionnaire, 12 months after radical prostatectomy. A change of 12 points in this domain is considered clinically relevant.

Secondary endpoints 8

1. 1. EPIC-26 sexual functioning domain score [0-100] at 6 months after RP. A difference of 12 points or more is considered clinically relevant.
2. 2. EPIC-26 sexual functioning domain score [0-100] at 24 months after RP. A difference of 12 points or more is considered clinically relevant.
3. 3. EPIC-26 urinary incontinence domain score [0-100] at 12 months after RP. A difference of 9 points or more is considered clinically relevant.
4. 4. EPIC-26 urinary incontinence domain score [0-100] at 24 months after RP. A difference of 9 points or more is considered clinically relevant.
5. 5. EPIC-26 hormonal functioning domain score [0-100] at 12 months after RP. A difference of 6 points or more is considered clinically relevant.
6. 6. EPIC-26 hormonal functioning domain score [0-100] at 24 months after RP. A difference of 6 points or more is considered clinically relevant.
7. 7. Occurrence of biochemical recurrence (two times detectable PSA > 0.2 ng/ml)
8. 8. In case of biochemical recurrence, time to recurrence in months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Canisius Wilhelmina Hospital

Sponsor organisation

Canisius Wilhelmina Hospital

Address

Weg Door Jonkerbos 100

City

Nijmegen

Postcode

6532 SZ

Country

Netherlands

Scientific contact point

Organisation

Canisius Wilhelmina Hospital

Contact name

Joost van Drumpt

Public contact point

Organisation

Canisius Wilhelmina Hospital

Contact name

Joost van Drumpt

Third parties 1

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications