← Back to Search

Hormone Therapy

Androgen Deprivation Therapy + Enzalutamide + Abiraterone for Prostate Cancer

Phase 2
Waitlist Available
Led By William L Dahut, 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My kidney function, measured by creatinine clearance, is adequate.
Select...
My prostate cancer diagnosis has been confirmed by a certified lab.
Select...
My prostate cancer has a Gleason score of 7.
Select...
My organ and bone marrow functions are within normal ranges.
Select...
I am at intermediate risk based on specific health features.
Select...
My prostate cancer is at an intermediate or high risk stage and has not been treated with surgery, medication, or radiation.
Select...
My cancer is at stage T2b or T2c.
Select...
My prostate cancer is aggressive (Gleason score 8 or higher).
Select...
My cancer has spread to the seminal vesicles.
Select...
My MRI might show cancer spread beyond the prostate capsule.
Select...
My cancer is at stage T4, meaning it has grown significantly.
Select...
I am eligible for and planning to have surgery to remove my prostate.
Select...
I am a man aged 18 or older.
Select...
I can carry out all my daily activities without help.
Select...
My prostate cancer can be seen on an MRI.
Select...
I agree to use effective birth control during and for 3 months after the study.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
disease status
Secondary outcome measures
pathological complete response rate

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
Abiraterone
2012
Completed Phase 4
~2830
18F-DCFPyL
2019
Completed Phase 3
~350
Prednisone
2014
Completed Phase 4
~2370
Radical Prostatectomy
2005
Completed Phase 2
~4550
goserelin
1999
Completed Phase 3
~5440
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,626 Previous Clinical Trials
40,927,624 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,171 Patients Enrolled for Prostate Cancer
William L Dahut, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
3,726 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,503 Patients Enrolled for Prostate Cancer
Fatima H Karzai, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
2,702 Total Patients Enrolled
2 Trials studying Prostate Cancer
2,201 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being sought for this experiment?

"That is right, the information available on clinicaltrials.gov demonstrates that this research project is still searching for individuals to take part. The study was first announced on April 30th, 2019 and has been updated as recently as October 4th, 2020. They are hoping to have a total of 30 people take part at 1 location."

Answered by AI

What medical procedures is Radical Prostatectomy commonly used to treat?

"Radical Prostatectomy is a common surgical intervention for prostate cancer. However, it can also be used to ameliorate the symptoms of other diseases such as thyroiditis, stage t2b carcinoma of the prostate, and ulcerative colitis."

Answered by AI

Are there other ongoing or completed research studies that focus on Radical Prostatectomy?

"527 studies on Radical Prostatectomy are ongoing, 145 of which are Phase 3. Germantown, Tennessee has the most active trials for this treatment, but there are a total of 27,424 locations running studies related to Radical Prostatectomy."

Answered by AI

Is it dangerous to go through with a Radical Prostatectomy?

"Given that there is only preliminary evidence supporting the safety of this surgical procedure, our team rates it as a 2."

Answered by AI

How many people fit the requirements to participate in this research?

"Yes, this is an ongoing recruitment as indicated by the most recent update on clinicaltrials.gov which was made on 10/4/2022. The study originally posted on 4/30/2019 and is still looking for 30 individuals from 1 site."

Answered by AI

Has this type of trial been conducted before?

"Radical Prostatectomy has been researched since 2000. The earliest trial occurred in 2000 and was sponsored by AstraZeneca. Following the first trial in 2000, which involved 600 patients, Radical Prostatectomy received its Phase 3 drug approval. Today there are 527 live trials for Radical Prostatectomy across 2640 cities and 71 countries."

Answered by AI
~2 spots leftby Aug 2025