Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cyproterone · 1 trial · 1 indication
The change is calculated as follows: \[(HF score at Week 4 of treatment - HF score at randomization)/HF score at randomization\]\*100. The calculation of the HF score will be done as follows: a coefficient is allocated to each severity grade, it varies from 1 to 4 (1: slight; 2: moderate; 3: severe; 4: very severe), and the calculation of the daily score is equal to the sum of the daily instances of hot flushes multiplied by their severity coefficient. The score calculated at randomization and Week 4 of treatment will be the average of the scores recorded in the preceding week. The score range will depend upon the frequency of hot flushes, and higher score signifies higher severity of hot flushes.
| Arm | Type | Description |
|---|---|---|
| Cyproterone acetate | EXPERIMENTAL | Leuprorelin 11.25 mg, injection, subcutaneously at Months 0, 3, and 6, and flutamide 250 mg, tablet, orally, thrice daily for first 30 days from first leuprorelin administration. From Month 6, cyproterone acetate 50 mg, tablet-in-capsule, along with cyproterone acetate placebo-matching capsule, orally, once daily in the morning and cyproterone acetate 50 mg, tablet-in-capsule, orally, once daily in the evening for 8 weeks. Cyproterone acetate placebo-matching capsule, orally, once daily in the morning for the next 2 weeks. |
| Medroxyprogesterone acetate | EXPERIMENTAL | Leuprorelin 11.25 mg, injection, subcutaneously at Months 0, 3, and 6, and flutamide 250 mg, tablet, orally, thrice daily for first 30 days from first leuprorelin administration. From Month 6, medroxyprogesterone acetate 10 mg, tablet-in-capsule, along with medroxyprogesterone acetate placebo-matching capsule, orally, once daily in the morning and medroxyprogesterone acetate 10 mg, tablet-in-capsule, orally, once daily in the evening for 8 weeks. Medroxyprogesterone acetate placebo-matching capsule, orally, once daily in the morning for the next 2 weeks. |
| Venlafaxine | EXPERIMENTAL | Leuprorelin 11.25 mg, injection, subcutaneously at Months 0, 3, and 6, and flutamide 250 mg, tablet, orally, thrice daily for first 30 days from first leuprorelin administration. From Month 6, venlafaxine 75 mg, capsule, orally, once daily in the morning and venlafaxine placebo-matching capsule, orally, once daily in the evening for 8 weeks. Venlafaxine 37.5 mg, capsule, orally, once daily in the evening for the next 2 weeks. |
| Name | Type | Description |
|---|---|---|
| Cyproterone acetate | DRUG | Cyproterone acetate tablet-in-capsule. |
| Medroxyprogesterone acetate | DRUG | Medroxyprogesterone acetate tablet-in-capsule. |
| Venlafaxine | DRUG | Venlafaxine capsule. |
| Leuprorelin | DRUG | Leuprorelin injection. |
| Flutamide | DRUG | Flutamide tablet |
| Placebo | DRUG | Cyproterone acetate, medroxyprogesterone acetate or venlafaxine placebo-matching capsule. |
Inclusion Criteria: - Patient has a histologically proven prostatic adenocarcinoma. * Patient has been on a gonadotropin releasing hormone (GnRH) agonist treatment for a duration of at least 1 year. * Karnofsky index greater than or equal to (\>=) 70 %. * Patient who, after having been clearly info...
Cyproterone is an investigational small molecule being studied for the treatment of adenocarcinoma of the prostate. It is currently in Phase 3 clinical development, with one completed trial evaluating its use in managing hot flushes caused by leuprorelin 11.25 mg in patients with prostate adenocarcinoma.
Cyproterone is a small molecule that acts as a steroidal antiandrogen. It works by blocking the effects of androgens, such as testosterone, which can promote the growth of prostate cancer cells. By inhibiting androgen receptor signaling, Cyproterone may help in the management of prostate adenocarcinoma.
Cyproterone is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK.
Cyproterone is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is being evaluated for its efficacy and safety in the treatment of prostate adenocarcinoma.
Cyproterone has one completed Phase 3 clinical trial registered under NCT01011751. The trial, titled 'Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Prostate Adenocarcinoma,' enrolled 311 male participants aged 18 years and older in France. The study was randomized, double-blind, and controlled.
Cyproterone is a steroidal antiandrogen, distinct from non-steroidal antiandrogens like bicalutamide or flutamide. It is being studied specifically for its role in managing hot flushes associated with androgen deprivation therapy in prostate adenocarcinoma, rather than as a primary cancer treatment.