Phase 2
N=7
Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02064582 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Enzalutamide (Drug); Leuprolide acetate (Drug); radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation |
— | — |
| SECONDARY Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy |
0.54; 2.2; 0.65; 0.36 | — |
Summary
The study is being done to find out whether combining two FDA approved drugs along with radiation therapy for the treatment of high risk localized prostate cancer is safe and well tolerated.
Eligibility Criteria
Inclusion Criteria
- histologically proven adenocarcinoma of the prostate within 6 months of screening
- Eastern Cooperative Oncology Group(ECOG) score 0-2
- adequate organ and and blood marrow function
- must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer
- patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment
- men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception
Exclusion Criteria
- prior treatment with agents known to have endocrine effects on prostate cancer
- treatment with corticosteroids within 4 weeks of enrollment
- treatment with androgens within 6 months of enrollment
- may not be receiving any other investigational agents
- Prostate specific antigen greater than 160ng/dL
- history of malignancy( other than non-melanoma skin cancer) within 5 years
- uncontrolled intercurrent illness
- cardiovascular event within 6 months of enrollment
- seizure or seizure disorder history
- contraindications to MRI- pacemakers, clips, etc
Data sourced from ClinicalTrials.gov (NCT02064582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.