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

Prostate Cancer Clinical Trial

Official title:

Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases: Clinical Testing and Feasibility of a Serum-based Metabolomics Profile

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02758132
• Other study ID #: Rosser 2015-1
• Status: Terminated
• Phase: Phase 2
• Start date: March 1, 2016
• Est. completion date: September 6, 2016

Study information

• Verified date: November 2019
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 6, 2016
• Est. primary completion date: September 6, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• 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.

Drug:
• Enzalutamide
160 mg enzalutamide by mouth daily
• Abiraterone
1000 mg abiraterone by mouth daily
• Prednisone
5 mg prednisone by mouth twice daily

Locations

Country	Name	City	State
United States	University of Hawaii Cancer Center	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measure Change in Technetium Bone Scintigraphy on Therapy Via Technetium Bone Scintigraphy or Sodium Fluoride (NaF) PET/CT Imaging		Prior to Registration, Day 1 of cycle 4 and 13, Post-Treatment Follow-up (up to 5 years post treatment)
Other	Measure Change in Treatment Response Via RECIST Criteria		Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment
Other	Evaluate the Effect of Therapy on Quality of Life (QoL) in Patients Via QoL Questionnaire.		Prior to Registration, Registration, Day 1 of cycle 4 and 13
Other	Evaluate the Effect of Therapy on Narcotic Use in Patients on Therapy Via Case Report Forms.		Prior to Registration, Registration, Day 1 of cycle 4 and 13
Primary	Measure Change in Serum-based Metabolites Associated With Bone Deposition, Growth and Turnover in Patients Who Have CRPC With Clinical Evidence of Metastatic Disease to the Bone, All Using Gas Chromatography-time-of-flight Mass Spectrometry (GC-TOFMS).		Prior to Registration, Registration, Day 1 of cycle 4 and 13
Secondary	Measure Time (Months) to Skeletal Related Event (SRE) of Patients on Therapy		Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment
Secondary	Measure Time (Months) to Progression-free Survival of Patients on Therapy		Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment
Secondary	Measure Time (Months) to Duration of Response of Patients on Therapy.		Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment