Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
degarelix · 1 trial · 1 indication
The primary outcome of N-cadherin and vimentin expression will be measured in post-treatment RP specimens. Comparisons amongst the various treatment groups (post-treatment inter-group) will be performed after all data have been collected.
| Arm | Type | Description |
|---|---|---|
| AR inhibition only | ACTIVE_COMPARATOR | AR inhibition only Group 1: degarelix + enzalutamide Endocrine therapy with degarelix and enzalutamide will continue for a minimum of 6 weeks and a maximum of 8 weeks in all groups prior to the planned prostatectomy. |
| AR inhibition plus MEK inhibition | ACTIVE_COMPARATOR | AR inhibition plus MEK inhibition Group 2: trametinib + degarelix + enzalutamide In Group 2, treatment with trametinib will begin on Day 29 (i.e. four weeks after initiation of androgen deprivation). Thus, trametinib will be administered for no less than two weeks and no more than four weeks. |
| AR inhibition plus SRC inhibition | ACTIVE_COMPARATOR | AR inhibition plus SRC inhibition Group 3: dasatinib + degarelix + enzalutamide In Group 3, treatment with dasatinib will begin on Day 29 (i.e. four weeks after initiation of androgen deprivation). Thus, dasatinib will be administered for no less than two weeks and no more than four weeks. |
| Name | Type | Description |
|---|---|---|
| degarelix | DRUG | Every 4-week Treatment: A starting dose of 240 mg of Degarelix is taken subcutaneously (SQ) -placed under the skin by injection- the first month. Doses continue every 4 weeks at 80 mg SQ. Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician. |
| enzalutamide | DRUG | Once Daily Treatment: A starting dose of 160 mg of Enzalutamide is taken by mouth once daily. Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician. |
| trametinib | DRUG | Once Daily Treatment: If randomized into Group 2, then 2mg of Trametinib is taken by mouth daily. Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician |
| dasatinib | DRUG | Once Daily Treatment: If randomized into Group 3, then 100mg of Dasatinib is taken by mouth daily. Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician |
Inclusion Criteria (patients must meet all of the following inclusion criteria to participate in this study) 1. Willing and able to give informed consent. 2. Adenocarcinoma of the prostate with planned RP with curative intent as part of standard of care management plan. 3. Patient is a candidate fo...
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Degarelix is a small molecule being studied for the treatment of prostate cancer. It is currently in Phase 2 clinical development as a neoadjuvant therapy, meaning it is given before the main treatment. The drug is being evaluated in an active, not recruiting clinical trial in the United States.
Degarelix is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by blocking the GnRH receptor, which reduces the production of testosterone, a hormone that can stimulate the growth of prostate cancer cells. This mechanism is being studied in the context of prostate cancer treatment.
Degarelix is being developed by Novartis AG, a global healthcare company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of degarelix for prostate cancer.
Degarelix is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities for general use. The ongoing Phase 2 trial is active but not recruiting participants, and it is being conducted in the United States.
Degarelix is being studied in a Phase 2 clinical trial with the identifier NCT01990196. This trial is titled 'Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer.' It is an active, not recruiting study with an enrollment of 45 male participants aged 18 years and older.
Degarelix is also known by the brand name FIRMAGON. FIRMAGON is the trade name under which degarelix is marketed. In the context of the ongoing clinical trial, the drug is referred to as degarelix, but it is the same compound as FIRMAGON.