Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases

• Status: Terminated
• Trial end date: 2016-09-06
• Target enrollment: 0
• Participant gender: Male

Summary

This is a correlative study to characterize serum metabolites associated with bone deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not currently receiving bone targeting agents.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Hawaii
• Treatments: Denosumab; Prednisone

Criteria

Inclusion Criteria:

• Histologic proof of adenocarcinoma of the prostate with clinical evidence of metastatic disease to the bone.

• Castrate resistant progression of prostate carcinoma, as shown by:

• Serum testosterone level <50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of testosterone should continue, and

• Either symptomatic progression, or, if patient is asymptomatic then a rising serum PSA in two occasions at least 1 week apart, with minimum pre-treatment serum PSA of 5 ng/dL.

• Patients with nodal disease are eligible.

• Bi-dimensionally measurable disease within the bone.

• Life expectancy of at least 12 weeks.

• ECOG Performance status < 2

• Adequate:

• Bone marrow function; absolute neutrophil count > 1,500 mm3, platelet count of > 100,000 mm3 and hemoglobin > 9.0 gm/dl.

• Hepatic function; SGOT/SGPT and conjugated bilirubin less than twice the upper limit of normal.

• Renal function; serum creatinine ≤ 2 mg/dL (or, if creatinine > 2 mg/dL, then a creatinine clearance of at least 35 ml/min (measured or estimated by the Cockroft formula:

CLcr = [(140-age) x wt (kg)]/[72 x serum creatinine (mg/dL)].

• No evidence of coagulopathy as indicated by PT < 1.5X upper limit of normal.

• Serum calcium (corrected) from 8 to11.5 mg/dL (2 to 2.9 mmol/L) - Patients must sign an informed consent indicating that they are aware of the investigational nature of the study.

Exclusion Criteria:

• Patients with variant histologies (e.g., ductal or small cell carcinoma).

• Patients with visceral disease are ineligible.

• Patients who have had prior Sipuleucel-T, docetaxel, cabazitaxel, abiraterone or enzalutamide as a single agent, or in combination therapy.

• Concurrent cancer chemotherapy, radiotherapy or surgery.

• Concurrent serious infection.

• Life threatening illness (e.g., congestive heart failure, uncontrolled angina or myocardial infarction in the prior six months).

• Hypertension uncontrolled by medication.

• Patients who are known to require invasive dental procedures.

• No known or suspected brain metastases (NOTE: patients with treated epidural disease are allowed)

• Administration of any investigational drug within 28 days prior to receipt of denosumab.

• Age ≤ 18 years of age