Castrate Sensitive Prostate CancerPhase 2NCT03860987
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer
A Phase 2 study testing goserelin, Enzalutamide and Abiraterone in people with Castrate Sensitive Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Castrate Sensitive Prostate Cancer
- What is being tested?
- goserelin, Enzalutamide and Abiraterone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 18 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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:
Show all 20Show fewer
- 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.
- Patients undergoing active treatment for Hepatitis B or C infections.
- Patients who have taken medications that are strong inhibitors or inducers of CYP3A4 or PgP within 14 days prior to enrollment and need to remain on these medications.
- Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) cannot be taken while patients are receiving enzalutamide and abiraterone.
- Contraindication to steroid use.
- Patients with malignancy within the past 3 years for which study drugs or a prostatectomy is a contraindication.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Study of Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18F-DCFPyL-PET/CT in Newly Diagnosed Prostate Cancer
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.
Read more
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...
Read the detailed description
Background:
- Most men diagnosed with prostate cancer will present with intermediate or high-risk disease, and many develop castrate resistant prostate cancer (CRPC) as curative strategies are often unsuccessful
- Treatment options typically involve radical prostatectomy (RP) or radiation therapy (RT) in combination with androgen deprivation therapy (ADT)
- PET imaging based on prostate specific membrane antigen (PSMA), including use of the radiotracer DCFPyL, which binds PSMA, has emerged as a sensitive modality to detect localized and metastatic prostate cancer
- It is unknown how androgen-targeted therapy affects expression of the androgen- regulated PSMA gene, FOLH1, and 18F -DCFPyL-PET/CT sensitivity; and, the correlation between response on 18F -DCFPyL-PET/CT imaging and clinical response needs further evaluation
- The use of highly effective androgen pathway inhibitors enzalutamide and abiraterone offers an opportunity to understand the characteristics of 18F -DCFPyL-PET imaging during treatment while potentially improving the cure rate of men with potentially lethal localized prostate cancer
- There remains a great need for improved techniques to determine mechanisms of treatment response and resistance
Objectives:
- To test the feasibility of 18F -DCFPyL-PET/CT for the localization of prostate cancer before, during, and after pre-operative treatment with ADT, enzalutamide, and abiraterone/prednisone in patients negative for metastatic disease
Eligibility:
- Pathologic diagnosis of castration-sensitive prostate cancer with intermediate- or high- risk features and no evidence of metastases beyond N1 on conventional imaging
- Candidates for radical prostatectomy
- Testosterone levels greater than or equal to 100 ng/dL
- ECOG PS 0-1
- Men age greater than or equal to 18 years
Design:
- Patients will be treated with ADT, enzalutamide, and abiraterone/prednisone for 6 months, followed by standard of care radical prostatectomy (RP)
- 18F-DCFPyL-PET/CT and mpMRI scans prior to treatment, during months 3-5 and after 6 months of treatment
- Prostate tumor biopsy (MR/US-guided) samples for research analyses at baseline and after mid-treatment imaging (post-month 2)
- It is anticipated that approximately 1.5 to 2 years may be required for accrual of up to 25 evaluable subjects.
- Conditions
- Castrate Sensitive Prostate Cancer
- Being tested
- goserelin, Enzalutamide, Abiraterone, 18F-DCFPyL, Prednisone
- Keywords
- Imaging, Prostatectomy, Anti-androgen Therapy, 18F-DCFPyL-PSMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
goserelinDrug
Goserelin will be administered SC at 10.8 mg every 12 weeks
EnzalutamideDrug
Enzalutamide will be given orally at 160mg once daily
AbirateroneDrug
Abiraterone will be taken orally at 1000 mg once daily
18F-DCFPyLDrug
18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging
PrednisoneDrug
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
Radical ProstatectomyProcedure or surgery
Radical Prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment Receives: Drug: goserelin; Drug: Enzalutamide; Drug: Abiraterone; Drug: 18F-DCFPyL; Drug: Prednisone; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease status
The primary endpoint will be the disease status after completion of treatment relative to PSMA-PET imaging findings at 2 months
Measured: 2 months
Secondary outcomes (1)
pathological complete response rate
Evaluate the pathological complete response rate after neoadjuvant treatment with ADT, enzalutamide, and abiraterone/prednisone
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start30 Apr 2019
- Primary completion11 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castrate Sensitive Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Fatima H Karzai, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860987
- Sponsor's protocol ID
- 190062
- Other IDs
- 19-C-0062
- Status last verified
- 20 May 2026
- First submitted
- 1 Mar 2019
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18F-DCFPyL-PET/CT in Newly Diagnosed Prostate Cancer
- ClinicalTrials.gov ID
- NCT03860987
- Acronym / sponsor ID
- 190062
- Conditions
- Castrate Sensitive Prostate Cancer
- Keywords
- Imaging, Prostatectomy, Anti-androgen Therapy, 18F-DCFPyL-PSMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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...
Detailed description
Background:
- Most men diagnosed with prostate cancer will present with intermediate or high-risk disease, and many develop castrate resistant prostate cancer (CRPC) as curative strategies are often unsuccessful
- Treatment options typically involve radical prostatectomy (RP) or radiation therapy (RT) in combination with androgen deprivation therapy (ADT)
- PET imaging based on prostate specific membrane antigen (PSMA), including use of the radiotracer DCFPyL, which binds PSMA, has emerged as a sensitive modality to detect localized and metastatic prostate cancer
- It is unknown how androgen-targeted therapy affects expression of the androgen- regulated PSMA gene, FOLH1, and 18F -DCFPyL-PET/CT sensitivity; and, the correlation between response on 18F -DCFPyL-PET/CT imaging and clinical response needs further evaluation
- The use of highly effective androgen pathway inhibitors enzalutamide and abiraterone offers an opportunity to understand the characteristics of 18F -DCFPyL-PET imaging during treatment while potentially improving the cure rate of men with potentially lethal localized prostate cancer
- There remains a great need for improved techniques to determine mechanisms of treatment response and resistance
Objectives:
- To test the feasibility of 18F -DCFPyL-PET/CT for the localization of prostate cancer before, during, and after pre-operative treatment with ADT, enzalutamide, and abiraterone/prednisone in patients negative for metastatic disease
Eligibility:
- Pathologic diagnosis of castration-sensitive prostate cancer with intermediate- or high- risk features and no evidence of metastases beyond N1 on conventional imaging
- Candidates for radical prostatectomy
- Testosterone levels greater than or equal to 100 ng/dL
- ECOG PS 0-1
- Men age greater than or equal to 18 years
Design:
- Patients will be treated with ADT, enzalutamide, and abiraterone/prednisone for 6 months, followed by standard of care radical prostatectomy (RP)
- 18F-DCFPyL-PET/CT and mpMRI scans prior to treatment, during months 3-5 and after 6 months of treatment
- Prostate tumor biopsy (MR/US-guided) samples for research analyses at baseline and after mid-treatment imaging (post-month 2)
- It is anticipated that approximately 1.5 to 2 years may be required for accrual of up to 25 evaluable subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: goserelin, Drug: Enzalutamide, Drug: Abiraterone, Drug: 18F-DCFPyL, Drug: Prednisone, Procedure: Radical ProstatectomyTreatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| goserelinGoserelin will be administered SC at 10.8 mg every 12 weeks | Drug | 1 |
| EnzalutamideEnzalutamide will be given orally at 160mg once daily | Drug | 1 |
| AbirateroneAbiraterone will be taken orally at 1000 mg once daily | Drug | 1 |
| 18F-DCFPyL18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging | Drug | 1 |
| PrednisonePrednisone 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 | Drug | 1 |
| Radical ProstatectomyRadical Prostatectomy | Procedure or surgery | 1 |
Primary outcome
disease status
Time frame: 2 months
The primary endpoint will be the disease status after completion of treatment relative to PSMA-PET imaging findings at 2 months
1 secondary outcome
pathological complete response rate
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
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JUR-003 in Adult Patients With Metastatic Prostate Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima H Karzai, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing goserelin, Enzalutamide and Abiraterone in people with Castrate Sensitive Prostate Cancer, run by National Cancer Institute (NCI) 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 0 inclusion and 20 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: finished, as of the sponsor's last update on 22 May 2026. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
disease status (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.