Prostate CancerPhase 2NCT03246347
A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer
A Phase 2 study testing ADT+Docetaxel+Enzalutamide in people with Prostate Cancer and Prostate Adenocarcinoma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- ADT+Docetaxel+Enzalutamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to Mar 2028
- 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
- Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small cell carcinoma or greater than 50% neuroendocrine differentiation. Metastatic disease must be present including soft tissue, and/or bone metastases OR nonregional lymph node involvement prior to study enrollment. If the subject has regional lymph node involvement, there must be at least one additional site of disease including visceral, non-regional nodal or skeletal metastases.
- ADT with surgical castration with bilateral orchiectomy or medical castration with LHRH agonist or LHRH antagonist therapy may have been initiated no greater than 112 days (16 weeks) prior to enrollment date. Subjects who initiated ADT prior to consent, are not eligible if PSA has risen ≥ 25% and ≥ 2 ng/ml above nadir value since initiation of ADT prior to consent.
- At least one PSA level of ≥ 5 ng/ml within 90 days prior to consent.
- Prior ADT for non-metastatic disease with LHRH agonist or LHRH antagonist therapy in the neoadjuvant/adjuvant setting is permitted if:
- Total duration of therapy did not exceed 36 months
- 6 months have elapsed since completion of therapy prior to consent,
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- Serum testosterone > 50 ng/dl within 28 days prior to reinitiation of ADT for metastatic disease
- Prior ADT for non-metastatic disease must have accompanied definitive local therapy for curative intent.
- Age ≥ 18 years.
- ECOG performance status 0-2.
- Adequate liver function: AST and ALT <1.5x upper limit of normal, total bilirubin < 1x upper limit of normal.
- Adequate bone marrow function: Platelets >100,000 cells/mm3, Hemoglobin > 8.0g/dL and ANC > 1,500 cells/mm3.
- Adequate renal function with a creatinine clearance (based on Cockcroft-Gault formula) ≥ 30 mL/min.
- Ability to understand and the willingness to sign a written informed consent document.
- Able to swallow and retain oral medication
Who cannot join
- Personal history of seizure.
- Personal history of conditions that may predispose to seizure activity including cortical cerebrovascular accident or brain trauma.
- Known central nervous system metastases, including involvement of brain parenchyma and leptomeninges.
- Personal history of any condition that may impair absorption of enzalutamide.
- Prior or current therapy with ketoconazole, abiraterone, enzalutamide, apalutamide (ARN-509, JNJ-56021927), darolutamide (ODM-201, BAY1841788) or cytotoxic chemotherapy such as docetaxel, cabazitaxel, cyclophosphamide.
- Prior therapy with bicalutamide, nilutamide or flutamide within 14 days of enrollment.
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- Within 28 days of major surgery and/or lack of recovery from prior surgical procedure or 14 days of palliative radiation prior to enrollment.
- Prior or current therapy with an investigational agent for metastatic prostate cancer.
- Known hypersensitivity to drugs formulated with polysorbate 80.
- Personal history of posterior reversible encephalopathy syndrome.
- CTCAE version 4.0 grade 2-4 peripheral sensory neuropathy.
- Human immunodeficiency virus infection or active hepatitis B or C infection.
- Uncontrolled and current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.
- Presence of any of the following within the previous 3 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
- History of an additional active malignancy within 12 months prior to the date of consent (except non-melanoma skin cancer).
- Current use of strong CYP2C8 inhibitors, CYP3A4 inducers or CYP3A4, CYP2C9 or CYP2C19 substrates with a narrow therapeutic range as listed in Section 7.2.1.
- Any condition that requires the use of prednisone > 10mg daily, or equivalent daily glucocorticoid dose, for greater than 14 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: A Phase II Trial of Androgen Deprivation, Docetaxel and Enzalutamide in Patients With Metastatic Hormone Sensitive Prostate Cancer
This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.
Read the detailed description
This is a single center, single arm, phase II trial designed to evaluate the 12 month PSA complete response rate in patients with metastatic hormone sensitive prostate cancer treated with ADT, docetaxel and enzalutamide. The primary endpoint of this study will be 12-month PSA complete response rate, which will be assessed against a contemporary historical control rate for the combination of ADT and docetaxel alone in the metastatic hormone naive setting. The study will be conducted at all participating sites across North and South Carolina within the Levine Cancer Institute network. Enrollment is anticipated to be completed within 24 months.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- ADT+Docetaxel+Enzalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADT+Docetaxel+EnzalutamideDrug
Also called Taxotere, Xtandi
combination therapy as listed above
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Docetaxel + Enzalutamide + Androgen Deprivation Therapy Receives: Drug: ADT+Docetaxel+Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
52-week PSA Complete Response (CR) Rate
The 52-week PSA CR rate was defined as the proportion of participants achieving PSA complete response (CR) at 52-weeks (+/- 1 week) from date of enrollment (i.e., initiation of both enzalutamide and docetaxel) of all evaluable participants. PSA CR was defined as PSA level less than 0.2 ng/ml for two consecutive measurements at least three weeks apart (date of initial PSA level 0.2 ng/ml was acknowledged as date of response). In subjects with missed PSA assessments at 52 (+/- 1) weeks, (a) if a confirmed CR was achieved and at least one PSA assessment occurred beyond the 52-week window showed serologic complete response (providing the subject did not earlier experience confirmed progressive disease), the subject achieved 52-week PSA Complete Response and (b) if confirmed CR was achieved before the 52-week window and the first assessment after the 52-week window was not a CR, the subject did not achieve a 52-week PSA Complete Response.
Measured: 52 weeks
Secondary outcomes (8)
Serologic Response Rate
Measured: Duration of study participation, an average of 2 years
Radiographic Response Rate
Measured: Duration of study participation, an average of 2-3 years
Time to Castrate Resistance
Measured: Duration of study participation, an average of 2 years
Serologic Progression Free Survival
Measured: Duration of study participation, an average of 2 years
Radiographic Progression Free Survival
Measured: Duration of study participation, an average of 2-3 years
Overall Survival
Measured: Duration of study participation, an average of 5 years
Time to Treatment Failure
Measured: Duration of study participation, an average of 2-3 years
Treatment-related Adverse Events as Assessed by CTCAE v4.0
Measured: Duration of study participation, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start23 Aug 2017
- Primary completion1 Sep 2022
- Study completionMar 2028 (estimated)
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc, Medivation, Inc.
- Responsible party
- Sponsor
- Investigators
- Earle Burgess, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246347
- Sponsor's protocol ID
- IRB00081385
- Other IDs
- LCI-GU-PRO-ADDE-001, Pro00018087
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2017
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Androgen Deprivation, Docetaxel and Enzalutamide in Patients With Metastatic Hormone Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT03246347
- Acronym / sponsor ID
- IRB00081385
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc, Medivation, Inc.
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 11 Aug 2017 (actual)
- Results
- Posted 22 Sep 2023
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 study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.
Detailed description
This is a single center, single arm, phase II trial designed to evaluate the 12 month PSA complete response rate in patients with metastatic hormone sensitive prostate cancer treated with ADT, docetaxel and enzalutamide. The primary endpoint of this study will be 12-month PSA complete response rate, which will be assessed against a contemporary historical control rate for the combination of ADT and docetaxel alone in the metastatic hormone naive setting. The study will be conducted at all participating sites across North and South Carolina within the Levine Cancer Institute network. Enrollment is anticipated to be completed within 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: ADT+Docetaxel+EnzalutamideDocetaxel + Enzalutamide + Androgen Deprivation Therapy |
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)
- Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small cell carcinoma or greater than 50% neuroendocrine differentiation. Metastatic disease must be present including soft tissue, and/or bone metastases OR nonregional lymph node involvement prior to study enrollment. If the subject has regional lymph node involvement, there must be at least one additional site of disease including visceral, non-regional nodal or skeletal metastases.
- ADT with surgical castration with bilateral orchiectomy or medical castration with LHRH agonist or LHRH antagonist therapy may have been initiated no greater than 112 days (16 weeks) prior to enrollment date. Subjects who initiated ADT prior to consent, are not eligible if PSA has risen ≥ 25% and ≥ 2 ng/ml above nadir value since initiation of ADT prior to consent.
- At least one PSA level of ≥ 5 ng/ml within 90 days prior to consent.
- Prior ADT for non-metastatic disease with LHRH agonist or LHRH antagonist therapy in the neoadjuvant/adjuvant setting is permitted if:
- Age ≥ 18 years.
Key exclusion criteria (17 listed)
- Personal history of seizure.
- Personal history of conditions that may predispose to seizure activity including cortical cerebrovascular accident or brain trauma.
- Known central nervous system metastases, including involvement of brain parenchyma and leptomeninges.
- Personal history of any condition that may impair absorption of enzalutamide.
- Prior or current therapy with ketoconazole, abiraterone, enzalutamide, apalutamide (ARN-509, JNJ-56021927), darolutamide (ODM-201, BAY1841788) or cytotoxic chemotherapy such as docetaxel, cabazitaxel, cyclophosphamide.
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 |
|---|---|---|
| ADT+Docetaxel+EnzalutamideAlso: Taxotere, Xtandicombination therapy as listed above | Drug | Single Arm |
Primary outcome
52-week PSA Complete Response (CR) Rate
Time frame: 52 weeks
The 52-week PSA CR rate was defined as the proportion of participants achieving PSA complete response (CR) at 52-weeks (+/- 1 week) from date of enrollment (i.e., initiation of both enzalutamide and docetaxel) of all evaluable participants. PSA CR was defined as PSA level less than 0.2 ng/ml for two consecutive measurements at least three weeks apart (date of initial PSA level 0.2 ng/ml was acknowledged as date of response). In subjects with missed PSA assessments at 52 (+/- 1) weeks, (a) if a confirmed CR was achieved and at least one PSA assessment occurred beyond the 52-week window showed serologic complete response (providing the subject did not earlier experience confirmed progressive disease), the subject achieved 52-week PSA Complete Response and (b) if confirmed CR was achieved before the 52-week window and the first assessment after the 52-week window was not a CR, the subject did not achieve a 52-week PSA Complete Response.
8 secondary outcomes
Serologic Response Rate
Time frame: Duration of study participation, an average of 2 years
Radiographic Response Rate
Time frame: Duration of study participation, an average of 2-3 years
Time to Castrate Resistance
Time frame: Duration of study participation, an average of 2 years
Serologic Progression Free Survival
Time frame: Duration of study participation, an average of 2 years
Radiographic Progression Free Survival
Time frame: Duration of study participation, an average of 2-3 years
Overall Survival
Time frame: Duration of study participation, an average of 5 years
Time to Treatment Failure
Time frame: Duration of study participation, an average of 2-3 years
Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Duration of study participation, an average of 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- 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.
Earle Burgess, MD principal investigator
Wake Forest University Health Sciences
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 ADT+Docetaxel+Enzalutamide in people with Prostate Cancer and Prostate Adenocarcinoma, run by Wake Forest University Health Sciences 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 17 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. 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 22 Sep 2023). 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?
52-week PSA Complete Response (CR) Rate (time frame: 52 weeks). 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 29 Jul 2026.