New combo therapy aims to halt returning prostate cancer
NCT ID NCT02203695
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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86 people
The number who actually took part.
- Started
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Mar 2015
- Finished
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Dec 2022
- Lead sponsor
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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
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18 to 100 years
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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
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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
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Indiana University
Lafayette, Indiana, 47904, United States
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Karmanos Cancer Center
Detroit, Michigan, 48201, United States
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Oregon Health Sciences University
Portland, Oregon, 97239, United States
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
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Suburban Hospital
Bethesda, Maryland, 20814, United States
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The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
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University of Chicago Medical Center
Chicago, Illinois, 60637, United States
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University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
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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.
- Can radiation boost a personalized prostate cancer vaccine?
- Can a custom vaccine train the body to fight prostate cancer?
- Targeted radiation plus hormone therapy may slow Low-Volume prostate cancer spread
- Could a depression drug fight prostate cancer?
- New blood test aims to spot prostate cancer cells earlier
- Glow-in-the-Dark antibody could help surgeons spot prostate cancer