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

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University of Hawaii

Status and phase

Terminated
Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Enzalutamide
Drug: Prednisone
Biological: Denosumab
Drug: Abiraterone

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:
Biological: Denosumab
Drug: Enzalutamide
Drug: Abiraterone
Drug: Prednisone
Standard of Care
Active Comparator group
Description:
Denosumab plus enzalutamide alone
Treatment:
Biological: Denosumab
Drug: Enzalutamide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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