Approval Probability
TA Base Rate
Adjusted LOA
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Also known as Androgen Deprivation Therapy (ADT)
Androgen Deprivation Therapy · 1 trial · 1 indication
rPFS is defined as the time from the first dose of systemic therapy for mCSPC to the first documented radiological progression in soft tissue or bone, based on CT, MRI, or NM bone scan, using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for soft-tissue metastases and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases, or death from any cause.
| Arm | Type | Description |
|---|---|---|
| Low Risk Prostate Cancer | EXPERIMENTAL | Low risk patients will receive 6-month doublet therapy with Androgen Deprivation Therapy (ADT) + Androgen Receptor Pathway Inhibitor (ARPI) + prostate radiation with or without radiation to metastatic sites followed by 30 months ARPI monotherapy. At a 36-month timepoint, those who maintain a prostate specific antigen (PSA) ≤ 0.2ng/mL will have the option to either discontinue treatment proceeding with active surveillance or continue on their ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans \[CT/MRI imaging per modified RECIST 1.1 or bone scan per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)\], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT. |
| High Risk Prostate Cancer | EXPERIMENTAL | High-risk patients will receive triplet therapy with ADT + ARPI + 6 cycles of docetaxel followed by 18-months of ADT + ARPI and then 12-month ARPI monotherapy. If a patient has high-risk disease but, based on the investigator's judgment, has contraindications to docetaxel or is deemed unsuitable for it, they will receive the same treatment regimen as other high-risk patients minus the docetaxel. Then at a 36-month timepoint, those who maintain a PSA ≤ 0.2ng/mL will have the option to either discontinue treatment with active surveillance or continue ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA (nadir) on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans \[CT/MRI imaging per modified RECIST 1.1 or bone scan per PCWG3\], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT. |
| Name | Type | Description |
|---|---|---|
| Androgen Deprivation Therapy (ADT) | DRUG | ADT, Gonadotropin-releasing hormone (GnRH) agonist or antagonists, as prescribed by the treating physician. |
| Androgen Receptor Pathway Inhibitor (ARPI) | DRUG | Darolutamide is the preferred ARPI for this study; however, patients may receive abiraterone, apalutamide, or enzalutamide at the discretion of their oncologist and based on patient preference. |
| Prostate Radiation | RADIATION | prostate radiation, with or without radiation to metastatic sites |
| Docetaxel | DRUG | Docetaxel will be administered as prescribed by the treating physician. |
Inclusion Criteria: 1. Adult patients with metastatic castrate sensitive prostate cancer that are eligible for standard of care (SOC) per treating physician. a. Low risk SOC: ADT + ARPI + radiation to the prostate i. For patients with low-risk disease (defined in Section 8.1), prior treatment w...
Androgen Deprivation Therapy (ADT) is used for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). It is being studied in a Phase 2 clinical trial to evaluate its effectiveness in this patient population. The therapy is part of a risk-adapted protocol designed for men with mHSPC.
Androgen Deprivation Therapy targets androgen receptors, which play a role in the growth of prostate cancer cells. By reducing androgen levels or blocking their action, ADT aims to slow or stop cancer progression. This mechanism is central to its use in metastatic hormone-sensitive prostate cancer.
Androgen Deprivation Therapy is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. The company is conducting a Phase 2 clinical trial for this therapy in metastatic hormone-sensitive prostate cancer.
Androgen Deprivation Therapy is currently in Phase 2 clinical development. It is an investigational therapy for metastatic hormone-sensitive prostate cancer and has not yet been approved by regulatory authorities. The ongoing trial is designed to assess its safety and efficacy in this indication.
Androgen Deprivation Therapy is being evaluated in a Phase 2 clinical trial with the identifier NCT07645326, titled 'RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)'. This trial is not yet recruiting and plans to enroll 108 male participants aged 18 years and older in the United States.
Yes, Androgen Deprivation Therapy is also known as ADT. The abbreviation ADT is commonly used in clinical and research settings to refer to this therapy. In the context of metastatic hormone-sensitive prostate cancer, ADT is being investigated as a treatment option.