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Adenocarcinoma of the ProstatePhase 1NCT02023463

Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer

A Phase 1 study testing Enzalutamide, Goserelin acetate and Leuprolide acetate in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Thomas Jefferson University at 1 site in United States.

Active, not recruiting

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

Official record
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Trial summary

This phase I trial studies the side effects and best way to give enzalutamide, radiation therapy, and hormone therapy in treating patients with intermediate or high-risk prostate cancer. Androgens can cause the growth of prostate cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Enzalutamide, Goserelin acetate and Leuprolide acetate
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
2 Apr 2014to 1 Jan 2040
Phase
Phase 1
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prostate adenocarcinoma without distant metastatic disease with either Gleason score ≥ 7, PSA ≥ 10 ng/ml, or T2b or greater disease
  • Age > 18
  • Performance Status: ECOG 0-1
  • Hematologic (minimal values):
  • Absolute neutrophil count > 1,500/mm3
  • Hemoglobin > 8.0 g/dl
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  • Platelet count > 100,000/mm3
  • Hepatic function
  • Total bilirubin < Upper limit of normal (ULN)(except for Gilbert's disease)
  • AST (SGOT) < 1.5 x ULN
  • ALT (SGPT) < 1.5 x ULN
  • Creatinine < 1.5 x ULN
  • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Who cannot join

  • Patients with a history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation or the use of concomitant medications that may lower the seizure threshold
  • History of urological surgery or procedures predisposing to GU complications after radiation (will be determined by radiation oncologist)
  • History of diverticulitis, rectal bleeding or other lower GI diseases predisposing to GI complications after radiation (will be determined by radiation oncologist)
  • History of prior chemotherapy or pelvic irradiation,
  • History of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin.
  • Documented distant metastatic disease. NOTE: pelvic lymphadenopathy is NOT excluded.
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  • Prior radical prostatectomy or cryosurgery for prostate cancer or bilateral orchiectomy.
  • No experimental medications within 30 days of study entry
  • Patients currently taking the following medications:
  • CYP2C8 inhibitors (e.g. Gemfibrozil)
  • CYP2C8 inducers (e.g. rifampin)
  • CYP3A4 inhibitors (itraconazole)
  • CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Phase Ib Trial of Enzalutamide in Combination With Radiation Therapy and LHRH Agonist Therapy in the Management of Intermediate and High-Risk Prostate Cancer

This phase I trial studies the side effects and best way to give enzalutamide, radiation therapy, and hormone therapy in treating patients with intermediate or high-risk prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. Giving enzalutamide, radiation therapy, and hormone therapy may be an effective treatment for prostate cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the safety of the combination of neoadjuvant and concurrent enzalutamide with an luteinizing-hormone-releasing hormone (LHRH) agonist and radiation therapy.

SECONDARY OBJECTIVES:

  1. To determine the efficacy of the combination of enzalutamide with an LHRH agonist and radiation therapy using prostate specific antigen (PSA) kinetics.
  2. To determine the efficacy of the combination of enzalutamide with an LHRH agonist and radiation therapy using PSA nadir.
  3. To describe patient-reported outcomes including: Expanded Prostate Cancer Index Composite (EPIC), American Urological Association (AUA) Symptom Index, PROstate magnetic resonance (MR) Imaging Study (PROMIS) Fatigue Scale.

OUTLINE:

Patients receive enzalutamide orally (PO) once daily (QD) for 6 months. Beginning 2 weeks after start of enzalutamide, patients receive LHRH agonist therapy with goserelin acetate subcutaneously (SC) or leuprolide acetate intramuscularly (IM) or SC for 6 months (intermediate risk patients) or 24 months (high risk patients) post-radiation therapy. Beginning 8 weeks after the start of LHRH agonist therapy, patients undergo either intensity modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) daily five days a week for 8 weeks.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Being tested
Enzalutamide, Goserelin acetate, Leuprolide acetate, Radiation therapy
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 Xtandi, MDV3100

    Given PO

  • Goserelin acetateDrug

    Also called Goserelin, Zoladex

    Given SC

  • Leuprolide acetateDrug

    Also called Leuprorelin, Leuprolide

    Given IM or SC

  • Radiation therapyRadiation

    Also called irradiation, radiotherapy, therapy, radiation

    Undergo image-guided radiation therapy

Study groups in NCT02023463
Study groupRoleWhat they receive
Treatment (enzalutamide, radiation therapy, hormone therapy)ExperimentalPatients receive enzalutamide PO QD for 6 months. Beginning 2 weeks after start of enzalutamide, patients receive LHRH agonist therapy with goserelin acetate SC or leuprolide acetate IM or SC for 6 months (intermediate risk patients) or 24 months (high risk patients) post-radiation therapy. Beginning 8 weeks after the start of LHRH therapy, patients undergo either IMRT or VMAT daily five days a week for 8 weeks.
Receives: Drug: Enzalutamide; Drug: Goserelin acetate; Drug: Leuprolide acetate; Radiation: Radiation therapy

What is being measured

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

  1. Acute toxicities, monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria

    An exact 2-sided binomial 90% confidence interval will be computed and reported. Toxicity will be monitored and if there is greater than 10% incidence of grade 3 or higher gastrointestinal (GI)/genitourinary (GU)/fatigue lasting more than 7 days despite optimal treatment, the trial will be re-evaluated.

    Measured: Up to 1 month post completion of enzalutamide

Secondary outcomes (2)

  1. Change in PSA levels

    Evaluated using linear mixed models. Mixed models will make use of all available data, and can estimate individual levels of change.

    Measured: Baseline up to 6 months

  2. Quality of life (QoL), measured using the EPIC, AUA symptom index, and the PROMIS Fatigue Scale

    QoL measures will also be assessed via linear mixed models, as an exploratory evaluation of potential clinical correlates, such as age, race, stage, Gleason score, etc.

    Measured: Baseline up to 1 year

Timeline

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

  1. First posted30 Dec 2013 (estimated)
  2. Study start2 Apr 2014
  3. Primary completion10 Jul 2017
  4. Study completion1 Jan 2040 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02023463
Sponsor's protocol ID
13P.461
Other IDs
2013-027, JT 2970
Status last verified
Nov 2025
First submitted
23 Dec 2013
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Enzalutamide, Goserelin acetate and Leuprolide acetate in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Thomas Jefferson University 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 13 inclusion and 13 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 25 Nov 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Acute toxicities, monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria (time frame: Up to 1 month post completion of enzalutamide). 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 NCT02023463.

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 25 Nov 2025.

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