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WithdrawnNCT02159690Updated Jan 26, 2015

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

A Phase 2 interventional study of Enzalutamide and Abiraterone acetate in Prostate Cancer and Localized Prostate Cancer, sponsored by Kenneth Pienta, MD. Withdrawn at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-26.

Sponsored by Kenneth Pienta, MD · Phase 2, Interventional, and Treatment

Why this study was withdrawn
loss of funding
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

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.

02

Conditions studied

  • Prostate Cancer
  • Localized Prostate Cancer

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Keywords

  • prostate cancer
  • prostatectomy
  • localized prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

Browse Prostatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Kenneth Pienta, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Willing and able to provide written informed consent.
  2. Age ≥ 18 years
  3. Eastern cooperative group (ECOG) performance status ≤2
  4. Documented histologically confirmed adenocarcinoma of the prostate
  5. Willing to undergo prostatectomy as primary treatment for localized prostate cancer
  6. 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
  7. Serum testosterone ≥150 ng/dL
  8. Able to swallow the study drugs whole as tablets
  9. 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).
  10. 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.

Exclusion criteria

Exclusion Criteria:

  1. Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
  2. Prior use of enzalutamide or abiraterone acetate

  3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:

    1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
    2. CYP-17 inhibitors (e.g. ketoconazole)
    3. Antiandrogens (e.g. bicalutamide, nilutamide)
    4. Second generation antiandrogens (e.g. enzalutamide, ARN-509)
    5. Immunotherapy (e.g. sipuleucel-T, ipilimumab)
    6. Chemotherapy (e.g. docetaxel, cabazitaxel)
  4. 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.
  5. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  6. Abnormal bone marrow function [absolute neutrophil count (ANC)\<1500/mm3, platelet count \<100,000/mm3, hemoglobin \<9 g/dL]
  7. Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
  8. Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
  9. 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.
  10. History of prior cardiac arrhythmia.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • DrugEnzalutamide

    160mg

    Also known as: MDV3100, Xtandi

  • DrugAbiraterone acetate

    1000mg

    Also known as: Zytiga

  • DrugPrednisone

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

    Also known as: Deltasone

  • DrugDutasteride

    0.5mg

    Also known as: Avodart

  • DrugDegarelix

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

    Also known as: Firmagon

06

What researchers measure

Primary outcomes

  1. Proportion of prostatectomy specimens with a complete response rate

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

    Time frame: 12 weeks

Secondary outcomes

  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

    Time frame: 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

    Time frame: 12 weeks

  3. Proportion of prostatectomy specimens with pathologic T3 disease

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

    Time frame: 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).

    Time frame: 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.

    Time frame: 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)

    Time frame: 64 weeks

  7. PSA progression free survival

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

    Time frame: 2 years after last accrual

  8. Overall survival

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

    Time frame: 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

    Time frame: 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.

    Time frame: 16 weeks

07

Study locations

1 site
  • Johns Hopkins Hospital
    Baltimore, Maryland 21231, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02159690
Lead sponsor
Kenneth Pienta, MD
Collaborators
Prostate Cancer Foundation Norway
Responsible party
Kenneth Pienta, MD (Principal Investigator, Johns Hopkins University) — Sponsor-investigator
First posted
Jun 10, 2014
Start date
Sep 2014
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Jan 26, 2015

Study contacts

Kenneth J Pienta, MD
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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