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New combo therapy and advanced scans aim to improve prostate cancer detection and treatment

NCT ID NCT03860987

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of three hormone-blocking drugs (enzalutamide, abiraterone, and standard hormone therapy) given before surgery in 12 men with newly diagnosed prostate cancer that hasn't spread. Researchers also used special PET/CT scans with a new tracer to see if they could better detect and track the cancer. The goal was to improve treatment and imaging, but men still needed surgery and long-term follow-up, so this is about controlling the disease, not curing it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

12 people

The number who actually took part.

Started

Apr 2019

Finished

May 2026

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

-INCLUSION CRITERIA: 1. 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. 2. 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 3. Patients must be eligible for and must be planning to undergo radical prostatectomy 4. Patients must have testosterone levels greater than or equal to 100 ng/dL 5. Men age greater than or equal to18 years. Children are excluded because prostate cancer is not common in pediatric populations. Women are not eligible because this disease occurs only in men. 6. ECOG performance status 0-1. 7. Patients must have adequate organ and marrow function, and other laboratory parameters as defined below: * hemoglobin greater than or equal to 9 g/dL * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) less than or equal to 3 X institutional upper limit of normal * creatinine within normal institutional limits; OR, * creatinine clearance greater than or equal to 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated via EGFR) 8. Lesions within prostate must be detectable on MRI for biopsy. 9. The effects of enzalutamide and abiraterone on the developing human fetus are unknown. For this reason and because androgen receptor antagonists as well as other therapeutic agents used in this trial are known to be teratogenic, male participants and their female partners of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence). Male participants should use a condom if having intercourse with a pregnant woman. Additionally, a condom plus another effective method of birth control is recommended during therapy and for 3 months after treatment for male participants having intercourse with a woman of reproductive potential. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately and her partner should inform the study team. 10. Ability of subject to understand and the willingness to sign a written informed consent document. 11. Willingness to adhere to protocol requirements (e.g., required biopsies). 12. Willingness to travel to NIH for follow-up visits. EXCLUSION CRITERIA: 1. Patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 1 day prior to registration). 2. Patients with evidence of distant metastatic disease beyond N1 (regional) lymph nodes on conventional imaging studies (e.g., CT, MRI or Bone Scan). 3. Patients who have received any prior definitive therapy (ie: surgery, systemic treatment or radiation therapy) for prostate cancer. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide, abiraterone or other agents used in study. 5. 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). 6. 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 7. 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 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. 9. 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. 10. Patients undergoing active treatment for Hepatitis B or C infections. 11. 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. 12. 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. 13. Contraindication to steroid use. 14. Patients with malignancy within the past 3 years for which study drugs or a prostatectomy is a contraindication.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.