A Phase 2 interventional study of Estetrol and Placebo Oral Tablet in Prostatic Neoplasm, sponsored by Pantarhei Oncology B.V.. Completed at 6 sites in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Pantarhei Oncology B.V. · Phase 2, Interventional, and Treatment
This is a phase IIa, double-blind, randomised, placebo-controlled, multi-center study to evaluate the effects of estetrol on testosterone suppression and quality of life in prostate cancer patients treated with an LHRH agonist. Patients will be treated with estetrol or placebo for 6 months.
Exclusion Criteria:
Drug: Estetrol
Drug: Placebo Oral Tablet
estetrol formulated in tablets
placebo tablets
Difference in total testosterone levels between treatment groups
Serum concentrations of total testosterone will be listed and summarized descriptively by treatment group. Nadir and time to nadir will be described using summary statistics.
Time frame: 168 days
Difference in free testosterone levels between treatment groups
Serum concentrations of free testosterone will be listed and summarized descriptively by treatment group. Nadir and time to nadir will be described using summary statistics.
Time frame: 168 days
Difference in mean daily hot flushes score between treatment groups
The number and severity in hot flushes will be assessed by means of a diary in which the patients records his hot flushes for 7 days.
Time frame: 168 days
Change from baseline in endocrine parameters, adrenal androgen, dihydrotestosterone (DHT) and Sex Hormone Binding Globulin (SHBG)
Effects on endocrine parameters (Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) and Estradiol (E2), adrenal androgens (Dehydroepiandrosterone sulfate (DHEAS)), dihydrotestosterone (DHT) and SHBG will be evaluated. Actual values at baseline and at the scheduled visits, as well as change from baseline values at the post-baseline visits will be described using summary statistics and graphs. Difference between the treatment groups will be evaluated.
Time frame: 168 days
Change from baseline in prostate-specific antigen (PSA) response
Effects on PSA response will be evaluated. Actual values at baseline and at the scheduled visits, as well as change from baseline and percentage change from baseline values at the post-baseline visits will be described using summary statistics and graphs. Nadir and time to nadir will be described using summary statistics. Difference between the treatment groups will be evaluated.
Time frame: 168 days
Questionnaire on Quality of Life
Effects on FACT-P questionnaire will be evaluated. FACT-P includes a 27-item "core" quality of life measure (FACT-G) grouped into 4 sub-scales: physical, social/family, emotional, and functional well-being. The prostate cancer-specific subscale contains an additional 12 items; 10 of which are prostate cancer specific physical problems. Items are rated on a 5-item Likert scale, from 0, "not at all", to 4, "very much". Total range of scores is from 0 - 156. Higher scores indicate higher degree of functioning and better quality of life. Total FACT-P scores, FACT-P general health subscale score (FACT-G) total score and all FACT-P subscale scores will be described at the scheduled visits using summary statistics and graphs. Differences between the treatment groups will be evaluated.
Time frame: 168 days
Change from baseline in lipids
Effects on total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol and Low Density Lipoprotein (LDL) cholesterol will be evaluated. Actual values at baseline and at the schedule visits as well as change from baseline values at the post-baseline visits will be described using summary statistics and graphs. Differences between the treatment groups will be evaluated.
Time frame: 168 days
Change from baseline in bone turnover markers
Effects on bone turnover markers osteocalcin and type I collagen telopeptide (CTX-1) will be evaluated. Actual values at baseline and at the schedule visits as well as change from baseline values at the post-baseline visits will be described using summary statistics and graphs. Differences between the treatment groups will be evaluated.
Time frame: 168 days
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Pantarhei Oncology B.V.