Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Apalutamide, IHT, BCR, Biochemical recurrence, intermittent hormone therapy Read More

Inclusion Criteria:

• Age ≥ 18 years
• Patients with a diagnosis of adenocarcinoma of the prostate
• Patients with BCR (PSA becomes detectable, with absolute value ≥1) following prostatectomy who have no evidence of metastatic disease based on radiographic assessment.
• Patients with BCR following radiation therapy who have no radiographic involvement per mpMRI and CT (RTOG-ASTRO Phoenix criteria), size of pelvic nodes ≤1 cm, and whose MRI-directed prostate biopsies are negative.
• Patients must be free of serious comorbidity as determined by investigator.
• Clinical laboratory values at screening:
• Serum testosterone level ≥150 ng/dL
• Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
• Platelet count ≥100,000 /µL independent of transfusion and/or growth factors within 3 months prior to randomization
• Serum albumin ≥3.0 g/dL
• GFR >45 mL/min
• Serum potassium ≥3.5 mmol/L
• Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
• Medications known to lower the seizure threshold (see list under prohibited meds, Appendix 3) must be discontinued or substituted at least 4 weeks prior to study entry.
• Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
• Written, informed consent to participate in this study.

Exclusion Criteria:

• PSA doubling time >12 months
• Positive for HIV or chronic hepatitis B or hepatitis C infection
• Another primary malignancy that has not been in remission for at least 2 years. Non-melanoma skin cancer allowed.
• Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of screening laboratory studies.
• Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements

• History of any of the following:

  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
  • Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization Any condition that in the opinion of the investigator, would preclude participation in this study

• Current evidence of any of the following:

  • Uncontrolled hypertension
  • Gastrointestinal disorder affecting absorption
  • Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) Any condition that in the opinion of the investigator, would preclude participation in this study