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Hormone Therapy

Androgen Deprivation Therapy + Enzalutamide + Abiraterone for Prostate Cancer

Phase 2
Waitlist Available
Led By Fatima H Karzai, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- creatinine clearance greater than or equal to 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated via EGFR)
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 not have
Contraindication to steroid use.
Patients with evidence of distant metastatic disease beyond N1 (regional) lymph nodes on conventional imaging studies (e.g., CT, MRI or Bone Scan).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat prostate cancer, as well as a new radiotracer to detect it. Eligible participants will take medication daily and receive injections, have monthly medical evaluations, and MRI and PET/CT scans. They may also need a biopsy.

Who is the study for?
Men 18+ with untreated prostate cancer that hasn't spread beyond regional lymph nodes. They must have a Gleason score of 7 or higher, normal organ function tests, and be eligible for surgery to remove the prostate. Participants need to agree to use contraception and attend follow-up visits at NIH.
What is being tested?
The trial is testing a combination of hormone-blocking drugs (abiraterone and enzalutamide) along with a new radiotracer (18F-DCFPyL) used in PET/CT scans for better detection and treatment of localized prostate cancer.
What are the potential side effects?
Possible side effects include hormonal changes due to androgen deprivation therapy, reactions from the radiotracer injection, discomfort from biopsies, surgical risks associated with prostatectomy, and typical medication-related issues like fatigue or digestive problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine clearance, is adequate.
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My prostate cancer diagnosis has been confirmed by a certified lab.
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My prostate cancer has a Gleason score of 7.
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My prostate cancer is at an intermediate or high risk stage and has not been treated with surgery, medication, or radiation.
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My cancer is at stage T2b or T2c.
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My prostate cancer is aggressive (Gleason score 8 or higher).
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My cancer has spread to the seminal vesicles.
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My cancer is at stage T4, meaning it has grown significantly.
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I am eligible for and planning to have surgery to remove my prostate.
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I am a man aged 18 or older.
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I can carry out all my daily activities without help.
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My prostate cancer can be seen on an MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take steroids due to health reasons.
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My cancer has spread beyond the regional lymph nodes.
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I have a bleeding disorder that makes prostate biopsy risky.
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I weigh more than the scanner's weight limit or cannot fit in it.
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I have had surgery, medication, or radiation for prostate cancer.
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I do not have severe heart problems or uncontrolled high blood pressure.
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I am currently being treated for Hepatitis B or C.
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I haven't taken strong CYP3A4 or PgP affecting drugs in the last 14 days.
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I haven't had cancer that would stop me from taking study drugs or having a prostatectomy in the last 3 years.
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I cannot undergo a biopsy due to medical reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
disease status
Secondary study objectives
pathological complete response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment6 Interventions
Treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Prostatectomy
2005
Completed Phase 2
~4550
goserelin
1999
Completed Phase 3
~5440
Enzalutamide
2014
Completed Phase 4
~3820
Abiraterone
2012
Completed Phase 4
~4570
18F-DCFPyL
2019
Completed Phase 3
~600
Prednisone
2014
Completed Phase 4
~2500

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,907 Previous Clinical Trials
41,012,133 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Fatima H Karzai, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
12,676 Total Patients Enrolled
2 Trials studying Prostate Cancer
2,175 Patients Enrolled for Prostate Cancer
William L Dahut, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
3,700 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,477 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03860987 — Phase 2
Prostate Cancer Research Study Groups: 1
Prostate Cancer Clinical Trial 2023: Abiraterone Highlights & Side Effects. Trial Name: NCT03860987 — Phase 2
Abiraterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03860987 — Phase 2
~1 spots leftby Aug 2025
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