Prostate CancerPhase 2NCT02758132
Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases
A Phase 2 study testing Denosumab, Enzalutamide and Abiraterone in people with Prostate Cancer, run by University of Hawaii at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Denosumab, Enzalutamide and Abiraterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 6 Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
About this study
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
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
- Being tested
- Denosumab, Enzalutamide, Abiraterone, Prednisone
- Keywords
- Castrate-resistant prostate cancer with bone metastases
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabBiological
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.
EnzalutamideDrug
160 mg enzalutamide by mouth daily
AbirateroneDrug
1000 mg abiraterone by mouth daily
PrednisoneDrug
5 mg prednisone by mouth twice daily
| Study group | Role | What they receive |
|---|---|---|
| Alliance A031201 | Active comparator | Denosumab plus enzalutamide, abiraterone and prednisone Receives: Biological: Denosumab; Drug: Enzalutamide; Drug: Abiraterone; Drug: Prednisone |
| Standard of Care | Active comparator | Denosumab plus enzalutamide alone Receives: Biological: Denosumab; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Prior to Registration, Registration, Day 1 of cycle 4 and 13
Secondary outcomes (3)
Measure Time (Months) to Skeletal Related Event (SRE) of Patients on Therapy
Measured: 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
Measure Time (Months) to Progression-free Survival of Patients on Therapy
Measured: 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
Measure Time (Months) to Duration of Response of Patients on Therapy.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start1 Mar 2016
- Primary completion6 Sep 2016
- Study completion6 Sep 2016
Why it stopped: Low accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758132
- Sponsor's protocol ID
- Rosser 2015-1
- Status last verified
- Nov 2019
- First submitted
- 11 Apr 2016
- Last updated
- 8 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02758132
- Acronym / sponsor ID
- Rosser 2015-1
- Conditions
- Prostate Cancer
- Keywords
- Castrate-resistant prostate cancer with bone metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accruals
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 6 Sep 2016 (actual)
- Study completion
- 6 Sep 2016 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alliance A031201 | Active comparator | Biological: Denosumab, Drug: Enzalutamide, Drug: Abiraterone, Drug: PrednisoneDenosumab plus enzalutamide, abiraterone and prednisone |
| Standard of Care | Active comparator | Biological: Denosumab, Drug: EnzalutamideDenosumab plus enzalutamide alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Patients with nodal disease are eligible.
- Bi-dimensionally measurable disease within the bone.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabOne 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. | Biological | Alliance A031201, Standard of Care |
| Enzalutamide160 mg enzalutamide by mouth daily | Drug | Alliance A031201, Standard of Care |
| Abiraterone1000 mg abiraterone by mouth daily | Drug | Alliance A031201 |
| Prednisone5 mg prednisone by mouth twice daily | Drug | Alliance A031201 |
Primary outcome
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).
Time frame: Prior to Registration, Registration, Day 1 of cycle 4 and 13
3 secondary outcomes
Measure Time (Months) to Skeletal Related Event (SRE) of Patients on Therapy
Time frame: 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
Measure Time (Months) to Progression-free Survival of Patients on Therapy
Time frame: 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
Measure Time (Months) to Duration of Response of Patients on Therapy.
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab, Enzalutamide and Abiraterone in people with Prostate Cancer, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Prior to Registration, Registration, Day 1 of cycle 4 and 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.