Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Prostatic Neoplasms

Hypogonadism

Gonadal Disorders

Endocrine System Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Androgens

Hormones

Hormone Antagonists

Daily application of two pump auctions of 16.2mg/ml testosterone gel. Dosage may be altered depending on clinical response

Daily application of two pump auctions of placebo gel.

Testosterone gel

Placebo

Joost van Drumpt, MSc

Rob Wijn, MD

Pim van Leeuwen, MD, PhD

Eric Vrijhof, MD, PhD

Max Bruins, MD, PhD

Harm van Melick, MD, PhD

Jean-Paul van Basten, MSc, PhD

Michiel Sedelaar, MD, PhD

Diederik Somford, MD, PhD

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).

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 parameters/endpoints:

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 patient's 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 and/or 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.

Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy

Functional recovery after radical prostatectomy will be assessed by EPIC-26 questionnaire, a Patient Reported Outcome Measure (PROM). Patients will be asked to complete this questionnaire online.

Clinical relevance (\>12 points) for sexual function domain score as measured by EPIC-26.

Clinical relevance (\>9 points) for Urinary incontinence domain score as measured by EPIC-26.

Clinical relevance (\>6 points) for hormonal functioning domain score as measured by EPIC-26.

Biochemical recurrence (BCR) is defined as the occurrence of measurable (\>0.1 ng/ml) prostate specific antigen (PSA), during routinely follow-up up to five years after surgery, determined at two different occasions with at least one week between them.The BCR-rate between the placebo and control group will be compared to determine the influence of testosterone therapy on BCR.

Besins Healthcare

Canisius-Wilhelmina Hospital

Reproductive Control Agents

Docetaxel

Leuprolide

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Hormonal

GnRh (Leuprolide)

Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)

Testosterone Gel

70 mg/m2 given on day o1 of each 3 week cycle

Dana Rathkopf, MD, PhD

We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.

Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Docetaxel Pharmacokinetic parameters for cycles 1 and 2.

Memorial Sloan Kettering Cancer Center

GnRh (Leuprolide): Leuprolide LUPRON

Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle

Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days

Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days

GnRh (Leuprolide): Leuprolide LUPRON

Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle

Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days

Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days

Total

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Dana Rathkopf

at 6 months post-treatment

at 18 months post-treatment

Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)

Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)

Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)

(Metastatic) GnRh (Leuprolide): Leuprolide LUPRON

Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle

Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days

Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)

PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy

Docetaxel clearance (Cycle 1)

Docetaxel clearance (Cycle 2)

All Participants

A population pharmacokinetic model was fit to the data from all individuals simultaneously using a non-linear mixed effects modeling. This was performed using NONMEM. The NONMEM model accounts for between-patient, between-course, and residual variability (random effects) as well as parameter differences predicted by covariates (fixed effects).

The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.

Overall Study

Skin and Connective Tissue Diseases

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Hypokinesia

Sexual Dysfunctions, Psychological

Dyskinesias

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Menopause

once daily transdermal testosterone gel, 300 mcg

testosterone gel

placebo gel

Michael C Snabes, MD, PhD

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

BioSante Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy	NCT04833426	Prostatic Neopl... Hypogonadism Testosterone De...	Testosterone ge... Placebo	18 Years -	Canisius-Wilhelmina Hospital
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer	NCT00587431	Prostate Cancer	GnRh (Leuprolid... Testosterone Ge... Docetaxel	18 Years -	Memorial Sloan Kettering Cancer Center
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women	NCT00612742	Hypoactive Sexu...	testosterone ge... placebo gel	50 Years -	BioSante Pharmaceuticals

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