Prostate CancerPhase 2NCT02213107
Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.
A Phase 2 study testing Enzalutamide and Dutasteride or finasteride in people with Prostate Cancer, run by University of Rochester at 2 sites in United States.
Trial summary
Determine the effect of enzalutamide and dutasteride or finasteride on the time to prostatic-specific antigen level increase in patients age 65 or older. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Enzalutamide and Dutasteride or finasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to 31 Oct 2023
- 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 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
- Patients with systemic prostate cancer as defined by either a) hormonal naïve metastatic prostate cancer with radiographic evidence of visceral or osseous metastasis or b) biochemical recurrence prostate cancer that fulfills all of the following criteria:
- A minimum of three rising prostatic-specific antigen levels with an interval of =/> 1 week between each test, The prostatic-specific antigen (PSA) value at the screening visit should be =/> 2 ng/ml prostatic-specific antigen doubling time ≤ 9 months.
- Patients should be 65 years or older. Patients who are deemed "not fit" by comprehensive geriatric assessment or at high risk for side effects as determined by the treating physician. A case report form will be used to document the specifics of why each eligible patient is not considered an ideal candidate.
- Serum testosterone level > 1.7 nmol/L (50 ng/dL) at the screening visit (non- castrate).
- Patients could have received hormonal therapy as part of definitive treatment for previous localized prostate cancer. However, they should be off any hormonal therapy for greater than six months prior to entry to clinical trial.
- Eastern Cooperative Oncology Group performance status of 0 to 2. Able to swallow the study drug and comply with study requirements.
Who cannot join
- Severe concurrent disease or infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
- Known brain metastases. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. However, if brain imaging studies are performed, they must be negative for disease.
- Patient is receiving treatment for another active malignancy excluding localized cutaneous squamous or basal cell carcinoma.
- Prior treatment for systemic prostate cancer. Prior treatment with enzalutamide. Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide,), ketoconazole, abiraterone, finasteride, dutasteride, estrogens, or chemotherapy in an adjuvant setting within 6 months of enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments.
- Treatment with therapeutic immunizations for prostate cancer (e.g., PROVENGE®) or plans to initiate treatment with any of these treatments during the study period.
- Use of herbal products that may decrease prostatic-specific antigen levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks of enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments during the study.
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- Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) and radioisotope therapy within 8 weeks of enrollment (Day 1 visit).
- Participation in a previous clinical trial of an investigational agent that blocks androgen synthesis within six months.
- Participation in a previous clinical trial of enzalutamide. Use of an investigational agent within 4 weeks of enrollment (Day 1 visit) or plans to initiate treatment with an investigational agent during the study.
- Have used or plan to use from 30 days prior to enrollment (Day 1 visit) through the end of the study the following medications known to lower the seizure threshold or increase or decrease the bioavailability of the drug.
- Concomitant use of strong or moderately strong Cytochrome P450 isozyme inducers:
- Strong Cytochrome P450 isoenzyme 2C8 inhibitors like gemfibrozil, Strong Cytochrome P450 isoenzyme 2C8 inducers like Rifampin, Strong Cytochrome P450 isoenzyme 3A4 inhibitors like Itraconazole, Aminophylline/theophylline, Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone), Bupropion, Class IA and Class III antiarrhythmics (e.g., amiodarone, bretylium, disopyramide, ibutilide, procainamide, quinidine, sotalol); Dolasetron, Droperidol, Lithium, Macrolide antibiotics (e.g., erythromycin, clarithromycin); Pethidine, Phenothiazine antipsychotics (e.g., chlorpromazine, mesoridazine, thioridazine); Pimozide, Tricyclic and tetracyclic antidepressants(e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
- History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months of enrollment (Day 1 visit), or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
- Clinically significant cardiovascular disease including:
- Myocardial infarction within 6 months, Uncontrolled angina within 3 months, Congestive heart failure New York Heart Association class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition scan performed within 3 months results in a left ventricular ejection fraction that is =/> 45%, hypotension (systolic blood pressure < 86 millimeters of mercury [mmHg] or bradycardia with a heart rate < 50 beats per minute, uncontrolled hypertension as indicated by a resting systolic blood pressure of 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening or Study Day 1 visit.
- Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).
- Major surgery within 4 weeks prior to enrollment (Day 1 visit). Absolute neutrophil count < 1,500/µL, platelet count < 100,000/µL, and hemoglobin < 5.6 mmol/L (9 g/dL) at the Screening visit; (NOTE: patients may not have received any growth factors or blood transfusions within 7 days of the hematologic laboratory values obtained at the Screening visit).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Wisconscin
Milwaukee, Wisconsin, 53226
University of Rochester
Rochester, New York, 14642
About this study
Official title: A Phase II Study of Enzalutamide Plus Dutasteride/Finasteride as First Line Treatment for Vulnerable Patients ≥ 65 Years With Systemic Prostate Cancer
Determine the effect of enzalutamide and dutasteride or finasteride on the time to prostatic-specific antigen level increase in patients age 65 or older.
Read the detailed description
The primary objective of this study is to determine the effect of enzalutamide and dutasteride or finasteride on the time to prostatic-specific antigen progression in patients aged 65 or older receiving this combination as first line treatment for systemic prostate cancer.
To determine the safety and toxicities of the study drug combination.
To determine the time to prostatic-specific antigen nadir from the start of study treatment and to evaluate the absolute prostatic-specific antigen nadir as a result of the study drug combination
- Conditions
- Prostate Cancer
- Being tested
- Enzalutamide and Dutasteride or finasteride
- Keywords
- prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide and Dutasteride or finasterideDrug
Use of either two oral drugs together
- Enzalutamide by mouth daily and dutasteride by mouth daily or
- Enzalutamide by mouth daily and finasteride by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide and dutasteride or finasteride | Experimental | Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride. Receives: Drug: Enzalutamide and Dutasteride or finasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Specific Antigen (PSA) Progression Free Survival
Percentage of participants with progression-free survival at 3 years. PSA disease progression is defined as an increase in the PSA that is >=25% and >=2 ng/ml above the nadir PSA value.
Measured: 3 years.
Secondary outcomes (3)
Absolute PSA Response
Lowest PSA value achieved.
Measured: up to approximately 8 years
Time to PSA Nadir
Time (months) to achieve the lowest PSA value compared to baseline PSA level
Measured: up to approximately 8 years
Number of Participants Who Experience a Treatment-related Adverse Events.
Adverse events will be defined according to CTCAE version 4.0.
Measured: up to approximately 8 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 2014 (estimated)
- Study startSep 2014
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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 University of RochesterThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunkit Fung, University of Rochester
- Investigators
- Chunkit Fung, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213107
- Sponsor's protocol ID
- 53018
- Status last verified
- Oct 2024
- First submitted
- 7 Aug 2014
- Last updated
- 13 Nov 2024
- 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 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Enzalutamide Plus Dutasteride/Finasteride as First Line Treatment for Vulnerable Patients ≥ 65 Years With Systemic Prostate Cancer
- ClinicalTrials.gov ID
- NCT02213107
- Acronym / sponsor ID
- 53018
- Conditions
- Prostate Cancer
- Keywords
- prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Posted 13 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the effect of enzalutamide and dutasteride or finasteride on the time to prostatic-specific antigen level increase in patients age 65 or older.
Detailed description
The primary objective of this study is to determine the effect of enzalutamide and dutasteride or finasteride on the time to prostatic-specific antigen progression in patients aged 65 or older receiving this combination as first line treatment for systemic prostate cancer.
To determine the safety and toxicities of the study drug combination.
To determine the time to prostatic-specific antigen nadir from the start of study treatment and to evaluate the absolute prostatic-specific antigen nadir as a result of the study drug combination
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide and dutasteride or finasteride | Experimental | Drug: Enzalutamide and Dutasteride or finasterideUse of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
- Patients with systemic prostate cancer as defined by either a) hormonal naïve metastatic prostate cancer with radiographic evidence of visceral or osseous metastasis or b) biochemical recurrence prostate cancer that fulfills all of the following criteria:
- A minimum of three rising prostatic-specific antigen levels with an interval of =/> 1 week between each test, The prostatic-specific antigen (PSA) value at the screening visit should be =/> 2 ng/ml prostatic-specific antigen doubling time ≤ 9 months.
- Patients should be 65 years or older. Patients who are deemed "not fit" by comprehensive geriatric assessment or at high risk for side effects as determined by the treating physician. A case report form will be used to document the specifics of why each eligible patient is not considered an ideal candidate.
- Serum testosterone level > 1.7 nmol/L (50 ng/dL) at the screening visit (non- castrate).
Key exclusion criteria (17 listed)
- Severe concurrent disease or infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
- Known brain metastases. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. However, if brain imaging studies are performed, they must be negative for disease.
- Patient is receiving treatment for another active malignancy excluding localized cutaneous squamous or basal cell carcinoma.
- Prior treatment for systemic prostate cancer. Prior treatment with enzalutamide. Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide,), ketoconazole, abiraterone, finasteride, dutasteride, estrogens, or chemotherapy in an adjuvant setting within 6 months of enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments.
- Treatment with therapeutic immunizations for prostate cancer (e.g., PROVENGE®) or plans to initiate treatment with any of these treatments during the study period.
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 |
|---|---|---|
| Enzalutamide and Dutasteride or finasterideUse of either two oral drugs together 1. Enzalutamide by mouth daily and dutasteride by mouth daily or 2. Enzalutamide by mouth daily and finasteride by mouth daily | Drug | Enzalutamide and dutasteride or finasteride |
Primary outcome
Prostate Specific Antigen (PSA) Progression Free Survival
Time frame: 3 years.
Percentage of participants with progression-free survival at 3 years. PSA disease progression is defined as an increase in the PSA that is >=25% and >=2 ng/ml above the nadir PSA value.
3 secondary outcomes
Absolute PSA Response
Time frame: up to approximately 8 years
Time to PSA Nadir
Time frame: up to approximately 8 years
Number of Participants Who Experience a Treatment-related Adverse Events.
Time frame: up to approximately 8 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- 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.
Chunkit Fung, M.D. principal investigator
University of Rochester
2 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 Enzalutamide and Dutasteride or finasteride in people with Prostate Cancer, run by University of Rochester at 2 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 7 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: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 13 Nov 2024). 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?
Prostate Specific Antigen (PSA) Progression Free Survival (time frame: 3 years.). 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 13 Nov 2024.