NCT02023463Active, not recruitingPhase 1
Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer
Phase Ib Trial of Enzalutamide in Combination With Radiation Therapy and LHRH Agonist Therapy in the Management of Intermediate and High-Risk Prostate Cancer
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
This phase I trial studies the side effects and best way to give enzalutamide, radiation therapy, and hormone therapy in treating patients with intermediate or high-risk prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. Giving enzalutamide, radiation therapy, and hormone therapy may be an effective treatment for prostate cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 23 Dec 2013
- Start date
- 2 Apr 2014
- Primary completion date
- 10 Jul 2017
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Prostate cancer
- NCT number
- NCT02023463
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 25
- From 2 Apr 2014 to the primary completion date, 10 Jul 2017
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- History of prior chemotherapy or pelvic irradiation,
- Prior radical prostatectomy or cryosurgery for prostate cancer or bilateral orchiectomy.
- No experimental medications within 30 days of study entry
- 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)
Other illness
- History of urological surgery or procedures predisposing to GU complications after radiation (will be determined by radiation oncologist)
- History of diverticulitis, rectal bleeding or other lower GI diseases predisposing to GI complications after radiation (will be determined by radiation oncologist)
- 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.
- Documented distant metastatic disease. NOTE: pelvic lymphadenopathy is NOT excluded.
Who the study is looking for
- Prostate adenocarcinoma without distant metastatic disease with either Gleason score ≥ 7, PSA ≥ 10 ng/ml, or T2b or greater disease
- Age \> 18
- Performance Status: ECOG 0-1
- Hematologic (minimal values):
- Absolute neutrophil count \> 1,500/mm3
- Hemoglobin \> 8.0 g/dl
- Platelet count \> 100,000/mm3
- 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
- Creatinine \< 1.5 x ULN
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.