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

University of Hawaii

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Biological: Denosumab; Drug: Abiraterone; Drug: Enzalutamide; Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT02758132

Rosser 2015-1

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1 participants in 2 patient groups

Alliance A031201

Active Comparator group

Description:

Denosumab plus enzalutamide, abiraterone and prednisone

Treatment:

Drug: Prednisone

Drug: Enzalutamide

Drug: Abiraterone

Biological: Denosumab

Standard of Care

Active Comparator group

Description:

Denosumab plus enzalutamide alone

Treatment:

Drug: Enzalutamide

Biological: Denosumab