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Stage II Prostate AdenocarcinomaPhase 2NCT02949284

Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

A Phase 2 study testing Abiraterone Acetate, Androgen Receptor Antagonist ARN-509 and Gonadotropin-releasing Hormone Analog in people with Stage II Prostate Adenocarcinoma and Stage III Prostate Adenocarcinoma, run by Rutgers, The State University of New Jersey at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause the growth of prostate cancer cells. Read more about this study

Who is it for?
Any age, men only
What is being tested?
Abiraterone Acetate, Androgen Receptor Antagonist ARN-509 and Gonadotropin-releasing Hormone Analog
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesUnited States
Study dates
20 Jun 2017to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically proven adenocarcinoma of the prostate and: Gleason > 8 OR prostatic specific antigen (PSA) > 20 and more than 1 positive core
  • Patients with Eastern Cooperative Oncology Group performance scale (ECOG PS) 0 or 1
  • Clinical stage T3 or less as demonstrated by abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) will be selected as the prostate is resectable
  • Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
  • Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
  • Serum albumin >= 3.0 g/dL
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  • Glomerular filtration rate (GFR) >= 45 mL/min
  • Serum potassium >= 3.5 mmol/L
  • Serum total bilirubin =< 1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 × ULN, subject may be eligible)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 × ULN
  • Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

Who cannot join

  • Clinical stage T4 (invasion into rectum or ureters) significantly increases the morbidity of the surgery
  • Patients with rectal or ureteral invasion will be considered to have unresectable disease
  • History of any of the following:
  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)
  • Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial within 6 months prior to randomization
  • Venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks) within 6 months prior to randomization
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  • Clinically significant ventricular arrhythmias within 6 months prior to randomization
  • Metastatic prostate cancer
  • Baseline moderate or severe hepatic impairment (Child-Pugh class B or C)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale Cancer Center

    New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: Randomized Three-Arm Trial to Evaluate the Effect of Neoadjuvant Apalutamide Alone or in Combination With Abiraterone Acetate and GnRH Agonist on Enhancing Surgical Outcome of Nerve-Sparing Radical Prostatectomy in Men With High-Risk Prostate Cancer

This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist ARN-509, abiraterone acetate, and gonadotropin-releasing hormone analog (GnRH agonist) may fight prostate cancer by lowering the levels of androgen the body makes. Prednisone may either kill the tumor cells or stop them from dividing. Giving androgen receptor agonist ARN-509 with or without abiraterone acetate, GnRH agonist and prednisone may work better in treating patients with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the effect of neoadjuvant androgen receptor antagonist ARN-509 (apalutamide) with or without abiraterone acetate, GnRH agonist, and prednisone on the feasibility of performing nerve-sparing radical prostatectomy (RP) in men with high-risk prostate cancer (PCa).

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive androgen receptor antagonist ARN-509 orally (PO) daily for 3 months. Patients then undergo radical prostatectomy.

ARM II: Patients receive GnRH agonist subcutaneously (SC) on day 1, androgen receptor antagonist ARN-509 PO daily PO for 4 times, abiraterone acetate PO daily for 4 times, and prednisone PO daily for 3 months. Patients then undergo radical prostatectomy.

ARM III: Patients undergo radical prostatectomy.

After completion of study treatment, patients are followed up for 2 years.

Being tested
Abiraterone Acetate, Androgen Receptor Antagonist ARN-509, Gonadotropin-releasing Hormone Analog, Prednisone, Quality-of-Life Assessment

What participants receive

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

  • Abiraterone AcetateDrug

    Also called CB7630, Zytiga

    Given PO

  • Androgen Receptor Antagonist ARN-509Drug

    Also called ARN-509

    Given PO

  • Gonadotropin-releasing Hormone AnalogBiological

    Also called GnRH Agonist, GnRH Analog, Gonadotropin-Releasing Hormone Agonist, Gonadotropin-Releasing Hormone Analogue

    Given SC

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radical ProstatectomyProcedure or surgery

    Also called Prostatovesiculectomy

    Undergo radical prostatectomy

Study groups in NCT02949284
Study groupRoleWhat they receive
Arm I (androgen receptor ARN-509, radical prostatectomy)ExperimentalPatients receive androgen receptor antagonist ARN-509 PO daily for 3 months. Patients then undergo radical prostatectomy.
Receives: Drug: Androgen Receptor Antagonist ARN-509; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Radical Prostatectomy
Arm II (ARN-509, abiraterone acetate, GnRH, prednisone, RP)Active comparatorPatients receive GnRH agonist SC on day 1, androgen receptor antagonist ARN-509 PO daily PO for 4 times, abiraterone acetate PO daily for 4 times, and prednisone PO daily for 3 months. Patients then undergo radical prostatectomy.
Receives: Drug: Abiraterone Acetate; Drug: Androgen Receptor Antagonist ARN-509; Biological: Gonadotropin-releasing Hormone Analog; Drug: Prednisone; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Radical Prostatectomy
Arm III (radical prostatectomy)Active comparatorPatients undergo radical prostatectomy.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Radical Prostatectomy

What is being measured

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

  1. Post-surgical potency rate defined as successful intercourse in half the attempts

    Each of the experimental arms will be compared to the surgery-only arm, so each test will be a 2.5% level one-sided test to control for the fact that there are two comparisons.

    Measured: At 12 months

Secondary outcomes (9)

  1. Change in tumor volume on pelvic MRI after neoadjuvant therapy

    Will be correlated with clinical outcomes before and after androgen receptor antagonist ARN-509 or androgen receptor antagonist ARN-509, GnRH agonist, prednisone plus abiraterone acetate.

    Measured: Baseline to week 13

  2. Number of patients with biochemical recurrence defined using the Prostate Cancer Clinical Trials Working Group 2 definition

    Measured: Up to 5 years

  3. Number of patients with pathological T0

    Measured: Up to 5 years

  4. Number of patients with positive surgical margins

    Measured: Up to 5 years

  5. Postoperative continence rate as determined by the American Urological Association Symptom Score (AUAss)

    Measured: Up to 24 months after surgery

  6. Postoperative potency rate as determined by the Sexual Health Inventory for Men and EPIC questionnaire

    Measured: Up to 24 months after surgery

  7. Postoperative continence rate as determined by the Expanded Prostate Cancer Index Composite (EPIC)

    Measured: Up to 24 months after surgery

  8. Quality of life as assessed by the AUAss questionnaires

    Measured: Up to 24 months after surgery

  9. Quality of life as assessed by the EPIC questionnaires

    Measured: Up to 24 months after surgery

Timeline

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

  1. First posted31 Oct 2016 (estimated)
  2. Study start20 Jun 2017
  3. Primary completionSep 2026 (estimated)
  4. Study completionJun 2027 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02949284
Sponsor's protocol ID
Pro20160000563
Other IDs
NCI-2016-01496, Pro20160000563, 081603, P30CA072720
Status last verified
Jul 2026
First submitted
21 Oct 2016
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang AY, Stein MN, Ghodoussipour S, Kim IY. Neoadjuvant Apalutamide With or Without Abiraterone Acetate Plus Prednisone and Gonadotropin-Releasing Hormone Agonist Prior to Nerve-Sparing Radical Prostatectomy in High-Risk Prostate Cancer: Protocol for a Randomized Phase 2 Trial. JMIR Res Protoc. 2026 Nov 3;15:e97886. doi: 10.2196/97886.

    PubMed 42976301

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate, Androgen Receptor Antagonist ARN-509 and Gonadotropin-releasing Hormone Analog in people with Stage II Prostate Adenocarcinoma and Stage III Prostate Adenocarcinoma, run by Rutgers, The State University of New Jersey 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 12 inclusion and 9 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 10 Aug 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Post-surgical potency rate defined as successful intercourse in half the attempts (time frame: At 12 months). 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 NCT02949284, which also lists 1 linked publication.

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 10 Aug 2026.

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