Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer

NCT03860987 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 19006219-C-0062
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Prostate cancer is a common cancer among men. There are several ways to treat it, including hormone blocking drugs, radiation therapy, and surgery. Researchers want to combine abiraterone and enzalutamide to see if there is a better way to treat prostate cancer. They also want to study a new radiotracer called 18F-DCFPyL, with the help of a scan called positron emission tomography/computed tomography (PET/CT) to see if there is a better way to detect prostate cancer. Objective: To develop improved techniques to localize and detect prostate cancer; and to develop new ways to treat prostate cancer Eligibility: Men ages 18 and older with prostate cancer that has not spread to other parts of the body Design:

• Participants will have a medical evaluation to determine eligibility for the study.
• Participants will take three different medications daily by mouth and receive two injections during the course of the study.
• Participants will have a medical evaluation monthly (for 6 months) while taking the medications.
• Participants will have prostate MRI and PET/CT scans before treatment, 2 months after starting treatment and again before surgery. The radiotracer will be given by injection about 2 hours before the whole-body scan. The PET/CT scan itself is about an hour.
• Participants may be asked to do a biopsy before treatment and 2 months after starting treatment.
• Participants will have a full medical evaluation before surgery to remove their prostate.
• Participants will have a follow-up visit 3 months after surgery and then as needed.
• Participants will be contacted once a year for their PSA and testosterone levels for 5 years...

Conditions

Castrate Sensitive Prostate Cancer

Keywords

Imaging; Prostatectomy; Anti-androgen Therapy; 18F-DCFPyL-PSMA

Outcome Measures

Primary Outcomes (1)

• disease status

  The primary endpoint will be the disease status after completion of treatment relative to PSMA-PET imaging findings at 2 months

  2 months

Secondary Outcomes (1)

• pathological complete response rate

  5 years

Study Arms (1)

1

EXPERIMENTAL

Treatment

Drug: goserelin; Drug: Enzalutamide; Drug: Abiraterone; Drug: 18F-DCFPyL; Drug: Prednisone; Procedure: Radical Prostatectomy

Interventions

goserelin DRUG

Goserelin will be administered SC at 10.8 mg every 12 weeks

1

Enzalutamide DRUG

Enzalutamide will be given orally at 160mg once daily

1

Abiraterone DRUG

Abiraterone will be taken orally at 1000 mg once daily

1

18F-DCFPyL DRUG

18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging

1

Prednisone DRUG

Prednisone will be taken orally at 5mg twice a day for each dose, or 10 mg once a day. Doses should be taken about 12 or 24 hours apart

1

Radical Prostatectomy PROCEDURE

Radical Prostatectomy

1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed prostate cancer confirmed by the Laboratory of Pathology, NCI, OR documented histopathological confirmation of prostate cancer from a CLIA-certified laboratory.
• Must have previously untreated (with definitive therapy ie: surgery, systemic treatment or radiation therapy) prostate cancer with intermediate or high risk features defined as:
• Intermediate risk (patient must have at least one of the features listed below):
• PSA level is between 10 and 20 ng/ml,
• Gleason score is 7, OR
• Stage T2b or T2c,
• High risk (patient must have at least one of the features listed below):
• PSA \> 20 at the time of diagnosis,
• Gleason 8 or higher,
• Seminal vesicle involvement,
• Possible (on MRI) extra-capsular extension (T3 disease), OR
• Clinical stage T4
• Patients must be eligible for and must be planning to undergo radical prostatectomy
• Patients must have testosterone levels greater than or equal to 100 ng/dL
• Men age greater than or equal to18 years.

You may not qualify if:

• Patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 1 day prior to registration).
• Patients with evidence of distant metastatic disease beyond N1 (regional) lymph nodes on conventional imaging studies (e.g., CT, MRI or Bone Scan).
• Patients who have received any prior definitive therapy (ie: surgery, systemic treatment or radiation therapy) for prostate cancer.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide, abiraterone or other agents used in study.
• Clinically significant cardiac disease, e.g., New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension (greater than or equal to 160/100 mmHg on two consecutive readings), myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG).
• Contraindication to biopsy:
• Bleeding disorders for which a prostate biopsy would pose a bleeding risk
• PT/PTT greater than or equal to 1.5 times the upper limit of normal
• Artificial heart valve
• Contraindication to MRI:
• Patients weighing more than the weight limit or unable to fit the scanner
• Allergy to MR contrast agent
• Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• HIV-positive patients on antiretroviral therapy are ineligible because of potential pharmacokinetic interactions with study drugs. However, patients with long-standing (\>5 years) HIV on antiretroviral therapy \> 1 month (undetectable HIV viral load and CD4 count \> 150 cells/microliter) may be eligible if the PI determines no anticipated clinically significant drug-drug interactions.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Interventions

Goserelin; enzalutamide; abiraterone; 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid; Prednisone

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Fatima H Karzai, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 4, 2019
• Study Start: April 30, 2019
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04-22

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)