Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New combo therapy aims to halt returning prostate cancer

NCT ID NCT02203695

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding the drug enzalutamide to standard radiation therapy can better control prostate cancer that has come back after surgery. Eighty-six men with rising PSA levels after prostate removal took part. The goal was to see if the combination could delay cancer progression more than radiation alone.

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

86 people

The number who actually took part.

Started

Mar 2015

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 100 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: * Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization for the release of personal health information. * Males aged 18 years of age and above * Patients must have adenocarcinoma of the prostate gland * Patients must have received primary treatment with radical prostatectomy. * Patients must have evidence of biochemical (PSA) relapse after prostatectomy * Patients must have PSA within study range * Patients must have non-metastatic (M0) disease, as defined by a lack of metastases seen on CT scan of the chest/abdomen/pelvis and whole-body radionuclide 99Technetium (Tc) bone scan, (or sodium fluoride PET scan) taken within 3 months of study entry. * Patients must have had node negative (pN0) disease found at the time of surgery. * Patients must have non-castrate levels of serum testosterone levels within study range. * Patients must not have previously received hormonal therapy (LHRH agonist, antiandrogen, or both), with the exception of neoadjuvant or adjuvant hormones given in conjunction with prostatectomy. * Patients must have Eastern Cooperative Oncology Group (ECOG)performance status of 0-1, and life expectancy greater 3 years. * Patients must have laboratory test results within the certain ranges * Patients must be disease-free from prior malignancies for greater than 3 years, with the exception of non-melanoma skin cancers and superficial urothelial cancers. * Patients must have the ability to swallow the study drug whole as a tablet or capsule. * Throughout study, male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration or per local guidelines where these require additional description of contraceptive methods. * Throughout the study, patients must use a condom if having sex with a pregnant woman. Exclusion Criteria: * Currently active second malignancy * Primary treatment with radiation therapy. * Radiographic or clinical evidence of local-regional tumor recurrence, * Concurrent use of other antiandrogens, estrogen-like agents, or 5a-reductase inhibitors. * Use of systemic corticosteroids equivalent to prednisone (inhaled corticosteroids are permitted). * Concurrent use of other anti-cancer agents or treatments. * Serious concurrent medical illnesses (including uncontrolled major cardiac, pulmonary, Child-Pugh C liver or psychiatric diseases) or active major infections (including HIV, Hepatitis A-C). * Clinically significant cardiovascular disease including: * Myocardial infarction within 6 months of Screening visit. * Uncontrolled angina within 3 months of Screening visit. * Congestive heart failure (within certain ranges) * History of clinically significant ventricular arrhythmias * Prolonged corrected QT interval * History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place. * Hypotension within certain ranges * Uncontrolled hypertension within certain ranges * Medications which lowers seizure threshold. * History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism. Also, history of loss of consciousness or transient ischemic attack within 12months of enrollment (Day 1 visit). * Patients taking medications that may have adverse interactions with enzalutamide

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Adenocarcinoma of the prostate are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Indiana University

    Lafayette, Indiana, 47904, United States

  • Karmanos Cancer Center

    Detroit, Michigan, 48201, United States

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • Suburban Hospital

    Bethesda, Maryland, 20814, United States

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Utah - Huntsman Cancer Center

    Salt Lake City, Utah, 84112, United States

More trials for these conditions

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