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

NCT ID: NCT02758132

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2016-09-06

Brief 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alliance A031201

Denosumab plus enzalutamide, abiraterone and prednisone

Group Type: ACTIVE_COMPARATOR

Denosumab

Intervention Type: BIOLOGICAL

One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.

Enzalutamide

Intervention Type: DRUG

160 mg enzalutamide by mouth daily

Abiraterone

Intervention Type: DRUG

1000 mg abiraterone by mouth daily

Prednisone

Intervention Type: DRUG

5 mg prednisone by mouth twice daily

Standard of Care

Denosumab plus enzalutamide alone

Group Type: ACTIVE_COMPARATOR

Denosumab

Intervention Type: BIOLOGICAL

One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.

Enzalutamide

Intervention Type: DRUG

160 mg enzalutamide by mouth daily

Interventions

Denosumab

One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.

Intervention Type: BIOLOGICAL

Enzalutamide

160 mg enzalutamide by mouth daily

Intervention Type: DRUG

Abiraterone

1000 mg abiraterone by mouth daily

Intervention Type: DRUG

Prednisone

5 mg prednisone by mouth twice daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

Rosser 2015-1

Identifier Type: -

Identifier Source: org_study_id