A Study of an Intermittent ADT Approach with Apalutamide Monotherapy in Participants with mCSPC
- Conditions
- Metastatic Castration-Sensitive Prostate Cancer (mCSPC)Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502686-24-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 246
1. Be =18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed consent., 2. Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate., 3. Metastatic prostate cancer disease documented by conventional imaging (eg, CT, MRI, or bone scan) and/or NGI demonstrating =2 distinct extraprostatic sites of metastasis. Note: When historical conventional imaging is not available, baseline examination must be done during screening., 4. No pathologic finding consistent with small cell, ductal, or neuroendocrine carcinoma of the prostate., 5. Testosterone levels >50 ng/dL at screening, except for those who may have received ADT prior to screening. Participants are allowed to have received up to 3 months of ADT prior to screening/enrollment. Another exception is for participants who receive hormonal replacement as part of gender-affirming care., 6. Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s), 7. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (eg, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy., 8. Participants with no underlying hepatic metastases are eligible if they have: - Aspartate aminotransferase (AST) <3 x upper limit of normal (ULN) - Alanine aminotransferase (ALT) <3 x ULN - Total bilirubin <1.5 x ULN (isolated total bilirubin =1.5 x ULN with conjugated [direct] bilirubin <1.5 xULN is allowed for those participants with known congenital nonhemolytic hyperbilirubinemias), 9. Participants with known hepatic metastases are eligible if they have: - AST <5 x ULN - ALT <5 x ULN - Total bilirubin <3 x ULN (isolated total bilirubin =3 x ULN with conjugated [direct] bilirubin <1.5 x ULN is allowed for those participants with known congenital nonhemolytic hyperbilirubinemias), 15.1 Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study., 10. Participants should have: - Hemoglobin =9.0 g/dL, without transfusion or growth factors within 1 week - Neutrophils =1.0 x 103/µL - Platelets =50 x 103/µL, without transfusion or growth factors within 1 week, 11. Human immunodeficiency virus-positive participants are eligible if they meet all of the following: a. No detectable viral load (ie, <50 copies/mL) at screening b. CD4+ count >300 cells/mm3 at screening c. No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening d. Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance/progression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening. Note: HAART that could interfere with study treatment is excluded (consult the sponsor for a review of medications prior to enrollment)., 12. A participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for at least
1. History of seizure or known condition that has been determined to significantly predispose to seizure per investigator (including, but not limited to, loss of consciousness within 1 year prior to screening, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)., 3. Known allergies, hypersensitivity, or intolerance to excipients of apalutamide (refer to the IB)., 4. Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled, hypertension, clinically significant arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease. Uncomplicated deep vein thrombosis is not considered exclusionary., 5. Gastrointestinal disorder affecting absorption., 6. Participant has active (new or progressive) brain metastases for whom the treating physician determines that central nervous system (CNS) specific treatment is required immediately or during the first cycle of therapy. Those with active (new or progressive) brain metastases for whom the treating physician determines that CNS specific treatment is not required immediately or during the first cycle of therapy are eligible for inclusion., 7. Participant with leptomeningeal disease related to cancer., 8. Prior treatment for metastatic prostate cancer, with the exception of =3 months of ADT combined with focal radiation to an oligometastatic site since the diagnosis of mCSPC. Note: 1 single course of palliative radiotherapy will be allowed prior to enrollment for symptomatic bone metastases (it can be conventional or stereotactic radiosurgery/stereotactic body radiotherapy). This course must have been completed at least 14 days prior to Screening. Note: Participants who received localized treatment for prostate cancer are eligible to enter the study. For localized or locally advanced prostate cancer, participants must have received =3 years total of ADT and all other forms of prior systemic therapies for prostate cancer and all such therapies were completed =1 year prior to the first dose of apalutamide (except for participants who receive hormonal replacement therapy as part of genderaffirming care.)., 9. Participant who received surgical intervention for the treatment of prostate cancer within 28 days of study drug initiation. Note: Participants are permitted to receive high dose radiotherapy (eg, palliative) to the prostate as part of their treatment plan as directed by their treating physician. However, participants should not receive high dose radiotherapy (eg, palliative) to the prostate within 4 weeks prior to randomization or after randomization., 14.1 Received an investigational treatment, blood product support, growth factor support or invasive surgical procedure (not including surgical castration) within 28 days or 5 half-lives (whichever is longer) before the planned first dose of study treatment or is currently enrolled in an investigational study., 16.1 Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. France Only: Protected Persons as defined by article
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method