Prostate CancerPhase 2Doce/EnzaNCT02685267
Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer
A Phase 2 study testing Docetaxel, Enzalutamide and Prednisone in people with Prostate Cancer, run by Prostate Cancer Clinical Trials Consortium at 5 sites in United States.
Trial summary
This is a prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same combination plus enzalutamide. 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?
- Docetaxel, Enzalutamide and Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2016to Aug 2017
- 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
- Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
- NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
- Males 18 years of age and above
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Having documented disease progression on enzalutamide defined by 1 or more of the following criteria:
- PSA progression according to PCWG2 criteria with 3 consecutive rising PSA measurements, all collected at least 1 week apart
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- Radiographic progression in soft tissue or bone by modified RECIST 1.1 for subjects with measurable disease; or
- Bone disease progression defined by 2 or more new lesions on 2 consecutive bone scans in the absence of falling PSA
- Patients who have not had a bilateral orchiectomy must have a plan to maintain effective GnRG-analogue therapy for the duration of the trial
- Serum testosterone level < 50 ng/dL at Screening visit
- ECOG PS: 0-1
- Throughout the study, male patients and their female partners of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:
- Condom (barrier method of contraception even if having sex with a pregnant woman)
- One of the following is required:
- Established use of oral, injected, or implanted hormonal method of contraception by the female partner
- Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner
- Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner
- Tubal litigation in the female partner
- Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy) for >6 months
- Patients must have adequate organ and marrow function as defined below
- Leukocytes >3,000/mm3
- absolute neutrophil count >1,500/mm3
- platelets >100,000/mm3
- total bilirubin within normal institutional limits (or <2X the upper limit of normal in those with Gilbert's disease)
- AST(SGOT)/ALT(SGPT) <1.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance* >45 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Estimated life expectancy of > 6 months
- Able to swallow the study drug as prescribed and comply with study requirements
Who cannot join
- Prior treatment with docetaxel-based chemotherapy
- Prior treatment with abiraterone acetate
- Prior treatment with cabazitaxel
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
- Ongoing investigational treatment
- Medical conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, cardiac disease that would, in the opinion of the investigator, make this protocol unreasonably hazardous
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- Major surgery within 4 weeks of enrollment
- Use of an investigational therapeutic agent with 4 weeks of enrollment
- History of seizure or any condition that may predispose to seizure.
- History of loss of consciousness or transient ischemic attack within 12 months of enrollment
- Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease) within last 3 months
- Grade > 2 treatment-related toxicity from prior therapy
- History of hypersensitivity to polysorbate 80
- Any known allergy to the compounds under investigation
- Any other condition which, in the opinion of the Investigator, would preclude participation in this trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
The University of Chicago
Chicago, Illinois, 60637
Decatur Memorial Hospital
Decatur, Illinois, 62526
NorthShore University HealthSytem - Kellogg Cancer Center
Evanston, Illinois, 60201
Univesity of Wisconsin
Madison, Wisconsin, 53705
About this study
Official title: A Phase II Randomized Prospective Trial of Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (CRPC) Patients Progressing on Enzalutamide
This is a prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same combination plus enzalutamide.
The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel in patients who failed or progressed while on enzalutamide would increase progression-free survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL) using validated scales.
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel, Enzalutamide, Prednisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
EnzalutamideDrug
PrednisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel/Prednisone | Active comparator | Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout Receives: Drug: Docetaxel; Drug: Prednisone |
| Docetaxel/Prednisone + Enzalutamide | Active comparator | Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. Receives: Drug: Docetaxel; Drug: Enzalutamide; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (Radiographic or Per PCWG2 Criteria)
The primary endpoint of the study is progression-free survival (PFS), defined as the time from randomization to disease progression. Progression will be evaluated using a combination of RECIST and Prostate Cancer Working Group 2 guidelines.
Measured: 1 year
Secondary outcomes (2)
PSA Response in the Standard Treatment Arm and Experimental Treatment Arm
PSA response measured according to Prostate Cancer Working Group 2 (PCWG2).
The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.
Measured: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), Day 231, and every 21 days through study completion (an average of 1 year)
Overall Survival
Measured: At both 1 year and 2 years from treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2017
- Study completionAug 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prostate Cancer Clinical Trials Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Astellas Pharma Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685267
- Sponsor's protocol ID
- c13-126
- Acronym
- Doce/Enza
- Status last verified
- Mar 2021
- First submitted
- 9 Feb 2016
- Last updated
- 9 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Prospective Trial of Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (CRPC) Patients Progressing on Enzalutamide
- ClinicalTrials.gov ID
- NCT02685267
- Acronym / sponsor ID
- Doce/Enza / c13-126
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Prostate Cancer Clinical Trials ConsortiumUniversity, hospital or other
- Collaborators
- University of Chicago, Astellas Pharma Inc
- Study start
- Feb 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 12 Mar 2021
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 prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same combination plus enzalutamide.
The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel in patients who failed or progressed while on enzalutamide would increase progression-free survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL) using validated scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel/Prednisone | Active comparator | Drug: Docetaxel, Drug: PrednisoneDocetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout |
| Docetaxel/Prednisone + Enzalutamide | Active comparator | Drug: Docetaxel, Drug: Enzalutamide, Drug: PrednisoneDocetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
- NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
- Males 18 years of age and above
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Having documented disease progression on enzalutamide defined by 1 or more of the following criteria:
Key exclusion criteria (15 listed)
- Prior treatment with docetaxel-based chemotherapy
- Prior treatment with abiraterone acetate
- Prior treatment with cabazitaxel
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
- Ongoing investigational treatment
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 |
|---|---|---|
| Docetaxel | Drug | Docetaxel/Prednisone, Docetaxel/Prednisone + Enzalutamide |
| Enzalutamide | Drug | Docetaxel/Prednisone + Enzalutamide |
| Prednisone | Drug | Docetaxel/Prednisone, Docetaxel/Prednisone + Enzalutamide |
Primary outcome
Progression-free Survival (Radiographic or Per PCWG2 Criteria)
Time frame: 1 year
The primary endpoint of the study is progression-free survival (PFS), defined as the time from randomization to disease progression. Progression will be evaluated using a combination of RECIST and Prostate Cancer Working Group 2 guidelines.
2 secondary outcomes
PSA Response in the Standard Treatment Arm and Experimental Treatment Arm
Time frame: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), Day 231, and every 21 days through study completion (an average of 1 year)
Overall Survival
Time frame: At both 1 year and 2 years from treatment start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Enzalutamide and Prednisone in people with Prostate Cancer, run by Prostate Cancer Clinical Trials Consortium at 5 sites 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 29 inclusion and 15 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 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 12 Mar 2021). 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?
Progression-free Survival (Radiographic or Per PCWG2 Criteria) (time frame: 1 year). 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 9 Apr 2021.