Status:
NOT_YET_RECRUITING
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Conditions:
Metastatic Cancer
Neoplasm, Prostate
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have succe...
Eligibility Criteria
Inclusion
- Veterans must meet the following to be eligible to participate:
- Be willing and able to provide written informed consent for the trial.
- Age ≥18 years of age on day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet-cell features, or small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.
- Have been receiving or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).
- High risk for the development of progression of disease/metastasis, defined as (i) a minimum of three rising PSA values (PSA1 \< PSA2 \< PSA3) at an interval of at least 1 week apart; (ii) a PSA level of 2 ng per milliliter (2 μg/L) or greater; and (iii) a PSA doubling time of 9 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists) as calculated with the use of the method of Pound et al.
- Has not received abiraterone acetate, enzalutamide, or apalutamide at the time of enrollment.
- Have a predicted life expectancy of \>12 months.
- For patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization.
- Able to swallow the study drug and comply with study requirements.
- Laboratory tests meet minimum safety requirements:
- Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN
- Renal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl
- Hematological: Absolute neutrophil count ≥1000/mm3, Platelet count ≥100,000/mm3; Hemoglobin \>9 g/dL Note: The presence of metastatic disease as assessed by any modality is not a contraindication for enrollment.
Exclusion
- Subjects with any of the following will not be enrolled:
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).
- Treatment with hormonal therapy (e.g., androgen receptor inhibitors, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization
- Other malignancy except: (a) Subjects who have been successfully treated and are disease free for 3 years; (b) a history of completely resected non-melanoma skin cancer; or (c) successfully treated in situ carcinoma.
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
- Deep vein thrombosis or pulmonary embolism in the past 3 months that in the opinion of the physician makes the patient medically unstable.
- Patients who are receiving any other investigational agents concurrently.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05422911
Start Date
June 30 2022
End Date
June 30 2026
Last Update
June 21 2022
Active Locations (1)
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1
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468