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Prostate CancerPhase 2NCT02159690

A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy

A Phase 2 study testing Enzalutamide, Abiraterone acetate and Prednisone in people with Prostate Cancer and Localized Prostate Cancer, run by Kenneth Pienta, MD at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study investigates the pathologic effects of the combination of enzalutamide, abiraterone acetate, dutasteride, and degarelix when given for 12 weeks prior to prostatectomy in men with localized 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, Localized Prostate Cancer
What is being tested?
Enzalutamide, Abiraterone acetate and Prednisone
Type of treatment
Injection or infusion
How many people
0 participants
Where
1 siteUnited States
Study dates
Sep 2014to Jan 2015
Phase
Phase 2
Are there results?
None posted in the registry

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.
  • Age ≥ 18 years
  • Eastern cooperative group (ECOG) performance status ≤2
  • Documented histologically confirmed adenocarcinoma of the prostate
  • Willing to undergo prostatectomy as primary treatment for localized prostate cancer
  • High risk prostate cancer (per NCCN criteria): Gleason score 8-10 or T3a or PSA > 20 ng/mL -Or- Very-high risk prostate cancer (per NCCN criteria): T3b -T4
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  • Serum testosterone ≥150 ng/dL
  • Able to swallow the study drugs whole as tablets
  • Willing to take abiraterone acetate on an empty stomach (no food should be consumed at least two hours before and for one hour after dosing).
  • Willing to use a condom if having sex with a pregnant woman, or use a condom and another effective method of birth control if having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with abiraterone.

Who cannot join

  • Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
  • Prior use of enzalutamide or abiraterone acetate
  • Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
  • Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
  • CYP-17 inhibitors (e.g. ketoconazole)
  • Antiandrogens (e.g. bicalutamide, nilutamide)
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  • Second generation antiandrogens (e.g. enzalutamide, ARN-509)
  • Immunotherapy (e.g. sipuleucel-T, ipilimumab)
  • Chemotherapy (e.g. docetaxel, cabazitaxel)
  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
  • Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  • Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL]
  • Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
  • Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
  • Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study.
  • History of prior cardiac arrhythmia.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21231

Other trials in United States

About this study

This study investigates the pathologic effects of the combination of enzalutamide, abiraterone acetate, dutasteride, and degarelix when given for 12 weeks prior to prostatectomy in men with localized prostate cancer.

Enzalutamide, an androgen receptor (AR) antagonist, blocks binding of testosterone to the AR as well as preventing nuclear translocation of the AR and DNA binding. Abiraterone acetate inhibits the CYP17 pathway, which is involved in the formation of androgens. Dutasteride is a 5-alpha-reductase inhibitor which blocks conversion of testosterone to dihydrotestosterone. Degarelix, a gonadotropin-releasing hormone (GnRH) antagonist, binds to GnRH receptors on the pituitary gland thus suppressing testosterone release from the testes.

Therefore it is hypothesized that the combination of enzalutamide, abiraterone acetate, dutasteride, and degarelix will result in near-complete AR inhibition and produce favorable pathologic changes after 12 weeks of therapy.

Being tested
Enzalutamide, Abiraterone acetate, Prednisone, Dutasteride, Degarelix
Keywords
prostate cancer, prostatectomy, localized prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called MDV3100, Xtandi

    160mg

  • Abiraterone acetateDrug

    Also called Zytiga

    1000mg

  • PrednisoneDrug

    Also called Deltasone

    5mg twice daily (to blunt mineralocorticoid side effects from abiraterone)

  • DutasterideDrug

    Also called Avodart

    0.5mg

  • DegarelixDrug

    Also called Firmagon

    240mg SC loading dose on day 1, then three 80mg SC injections every 4 weeks thereafter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of prostatectomy specimens with a complete response rate

    Proportion of prostatectomy specimens with complete response rate after 12 weeks of therapy

    Measured: 12 weeks

Secondary outcomes (10)

  1. Proportion of prostatectomy specimens with a negative surgical margin rate

    Proportion of prostatectomy specimens with a negative surgical margin rate after 12 weeks of therapy

    Measured: 12 weeks

  2. Proportion of prostatectomy specimens with a near-pathologic complete response

    Proportion of prostatectomy specimens with a near-pathologic complete response (<=5mm of residual tumor) after 12 weeks of therapy

    Measured: 12 weeks

  3. Proportion of prostatectomy specimens with pathologic T3 disease

    Proportion of prostatectomy specimens with pathologic T3 disease after 12 weeks of therapy

    Measured: 12 weeks

  4. Change in immunologic parameters (TREC levels and antibody responses)

    Change in immunologic parameters (TREC levels and antibody responses) after 12 weeks of enzalutamide, abiraterone acetate, dutasteride and degarelix and an additional month of degarelix monotherapy (16 weeks total).

    Measured: 16 weeks

  5. Proportion of radiographic disappearance of MRI detectable significant prostate nodules

    Proportion of radiographic disappearance of MRI detectable significant prostate nodules after 12 weeks of therapy.

    Measured: 12 weeks

  6. Proportion of men who receive adjuvant radiation therapy within 1 year of prostatectomy

    Proportion of men who receive adjuvant radiation therapy within 1 year of prostatectomy (12 weeks of therapy + 1 year = 64 weeks)

    Measured: 64 weeks

  7. PSA progression free survival

    The biochemical (i.e. PSA) progression free survival estimate two years after the last patient has accrued.

    Measured: 2 years after last accrual

  8. Overall survival

    The overall survival estimate two years after the last patient has accrued.

    Measured: 2 years after last accrual

  9. Incidence and severity of adverse events

    Safety as assessed by the incidence and severity of adverse events and serious adverse events graded according to the National Cancer Institute - Common Terminology Criteria for adverse events (CTCAE) version 4.0

    Measured: 16 weeks

  10. Exploratory biomarkers assessment

    Exploratory biomarker Assessment. Examples of these may include, but are not limited to: assessment for genomic PTEN loss via fluorescence in situ hybridization (FISH), PTEN immunohistochemistry (IHC), assessment for alteration in MYC/chromosome 8q24 via FISH, RNAseq analysis, serum drug/androgen levels and intraprostatic drug/androgen levels.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: loss of funding

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02159690
Sponsor's protocol ID
Neoadj enz/abi/dut/deg
Status last verified
Jan 2015
First submitted
6 Jun 2014
Last updated
26 Jan 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide, Abiraterone acetate and Prednisone in people with Prostate Cancer and Localized Prostate Cancer, run by Kenneth Pienta, MD 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 10 inclusion and 16 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: withdrawn, as of the sponsor's last update on 26 Jan 2015. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Proportion of prostatectomy specimens with a complete response rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02159690.

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 26 Jan 2015.

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