Triple therapy shows promise for aggressive prostate cancer
NCT ID NCT02023463
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of enzalutamide (a hormone-blocking drug), radiation therapy, and standard hormone therapy in 25 men with intermediate or high-risk prostate cancer. The main goal was to check for side effects and find the best way to give the treatment. Researchers also tracked PSA levels and quality of life. The approach aims to control the disease, not cure it, as ongoing hormone therapy is typically needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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Apr 2014
- Expected to finish
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Jan 2040
An estimate. End dates often move.
- 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 years and older
- 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: 1. Prostate adenocarcinoma without distant metastatic disease with either Gleason score ≥ 7, PSA ≥ 10 ng/ml, or T2b or greater disease 2. Age \> 18 3. Performance Status: ECOG 0-1 4. Hematologic (minimal values): * Absolute neutrophil count \> 1,500/mm3 * Hemoglobin \> 8.0 g/dl * Platelet count \> 100,000/mm3 5. Hepatic function * Total bilirubin \< Upper limit of normal (ULN)(except for Gilbert's disease) * AST (SGOT) \< 1.5 x ULN * ALT (SGPT) \< 1.5 x ULN 6. Creatinine \< 1.5 x ULN 7. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. Exclusion Criteria: 1. Patients with a history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation or the use of concomitant medications that may lower the seizure threshold 2. History of urological surgery or procedures predisposing to GU complications after radiation (will be determined by radiation oncologist) 3. History of diverticulitis, rectal bleeding or other lower GI diseases predisposing to GI complications after radiation (will be determined by radiation oncologist) 4. History of prior chemotherapy or pelvic irradiation, 5. History of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin. 6. Documented distant metastatic disease. NOTE: pelvic lymphadenopathy is NOT excluded. 7. Prior radical prostatectomy or cryosurgery for prostate cancer or bilateral orchiectomy. 8. No experimental medications within 30 days of study entry 9. Patients currently taking the following medications: * CYP2C8 inhibitors (e.g. Gemfibrozil) * CYP2C8 inducers (e.g. rifampin) * CYP3A4 inhibitors (itraconazole) * CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine)
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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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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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Other studies related to the condition(s) this trial covers.
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