NCT02491411

Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel

A Pilot Study of Dexamethasone Therapy Prior to Rechallenge With Enzalutamide in Men With Metastatic Castration-Resistant Prostate Cancer Dex EXTends Enza Response (The DEXTER Trial)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot trial studies how well dexamethasone and re-treatment with enzalutamide work in treating patients with prostate cancer that has spread to other places in the body (metastatic), does not respond to hormone therapy (hormone-resistant), and was previously treated with enzalutamide and docetaxel. Dexamethasone treatment may be able to reverse one resistance mechanism to enzalutamide therapy (overabundance of receptors for dexamethasone and other glucocorticoids inside cancer cells) and allow for renewed therapeutic sensitivity to enzalutamide. Androgens (a type of male hormone) can bind to androgen receptors found inside prostate cancer cells, which may cause the cancer cells to grow. Enzalutamide may stop the growth of prostate cancer cells by blocking the activity of the cancer cell androgen receptors. Giving dexamethasone prior to re-treatment with enzalutamide may be a treatment for prostate cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the prostate-specific antigen (PSA) response rate to enzalutamide (Enza) after treatment with dexamethasone (Dex) therapy. SECONDARY OBJECTIVES: I. Objective response rate to Enza in patients with measurable disease on computed tomography (CT) scan using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. II. Time to PSA progression (based upon Prostate Cancer Working Group 2 \[PCWG2\] criteria) for treatment with Dex. III. Effect of each treatment on quality of life as assessed by patient completion of validated instruments (Functional Assessment of Chronic Illness Therapy \[FACIT\]-Fatigue Scale, RAND Short Form-36 \[RANDSF-36\]). IV. PSA response rates to Dex for patients who are androgen receptor splice variant 7 (AR-V7) positive and AR-V7 negative, respectively, at study entry. V. Response rates to Enza for patients who are AR-V7 positive and AR-V7 negative, respectively, at study entry. VI. Percentage of patients who are AR-V7 positive at study entry who are AR-V7 negative at time of initiation of Enza, or vice-versa. OUTLINE: Patients receive dexamethasone orally (PO) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until there is evidence of PSA progression, clinical disease progression, or radiographic disease progression. At time of progression, dexamethasone will be stopped via a rapid taper over one week if patients were treated for over 30 days. Patients then receive enzalutamide PO once daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of clinical disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.

Conditions

• Hormone-Resistant Prostate Cancer
• Metastatic Prostate Carcinoma
• Prostate Adenocarcinoma
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given PO
DRUG	Enzalutamide	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-07-08
• Last updated: 2018-07-12
• Results posted: 2018-07-12

Locations

1 site across 1 country: United States