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A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer

Status
Active
Cancer Type
Prostate Cancer
Trial Phase
Phase II
Eligibility
18 and over, Male
Study Type
Treatment
NCD ID
NCT02286921
Protocol IDs
J14146 (primary)
NA_00046414
Study Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Summary

Asymptomatic men with progressive metastatic CRPC post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a dose/schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near castrate levels [i.e. Bipolar Androgen Therapy (BAT)] will improve primary and secondary objectives vs. enzalutamide as standard therapy.

Objectives

Eligible patients will have metastatic CRPC with no disease related symptoms and progression on ADT and will have progressed post-treatment with abiraterone. Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard or Lupron) or LHRH antagonist (Degarelix) if not surgically castrated throughout the duration of the study to inhibit endogenous testosterone production. Patients will be randomized 1:1 and stratified based on duration of prior abiraterone acetate therapy (6 months or less or greater than 6 months). Patients randomized to BAT (Arm A) will receive intramuscular injections with either testosterone cypionate or testosterone enanthate at a dose of 400 mg every 28 days. This dose was selected based on data demonstrating that it produces an initial supraphysiologic serum level of T (i.e. > 1500 ng/dL or 3-10 times normal level) with eugonadal levels achieved at the end of two weeks and near castrate levels after 28 days. Patients randomized to enzalutamide (Arm B) will receive daily oral dose of 160 mg. Each cycle is defined as 28 days.

Patients will have PSA level and symptoms assessment checked every cycle. Every 3 cycles patients will have repeat bone/CT scans to evaluate treatment response status. On CT scan, radiographic progression will be defined by RECIST criteria (i.e. >20% increase in the sum of target lesions). On bone scan, radiographic progression will be defined by PCWG2 criteria as = 2 new bone lesions. However, for the first reassessment scan only, patients should remain on study and have a confirmatory scan performed 12 weeks (3 cycles) later. If this confirmatory scan shows 2 or more additional new lesions, this defines progression. The date of progression is the date of the first reassessment bone scan. If the confirmatory scan does not show any additional new lesions, patient remains on study. If progression is observed on subsequent bone scans, a confirmatory scan is not required; the date of this bone scan is the date of progression.

Patients with PSA progression but with disease response or stable disease on imaging studies will remain on study until radiographic or other clinical progression criteria are met. Patients with radiographic disease progression will not receive continued BAT (arm A) or enzalutamide (arm B) and will be eligible for crossover to the opposite therapy. Patients on the BAT arm A can cross over to receive enzalutamide at time of progression or can choose to go off study and be treated with other standard of care treatments. Patients on the enzalutamide arm B will be allowed to cross-over to receive BAT or can choose to go off study and be treated with other standard of care treatments.

Treatment Sites in Georgia

Piedmont Cancer Institute - Fayetteville


1267 Highway 54 West
Suite 4200
Fayetteville, GA 30214
www.piedmontcancerinstitute.com

Study Coordinator:
Ann Johnston
678-298-3235

Doctors:

Jonathan C. Bender MD
Trevor M. Feinstein MD
Rajni Sinha MD

Piedmont Cancer Institute - Newnan


775 Poplar Road
Suite 310
Newnan, GA 30265
www.piedmontcancerinstitute.com

Study Coordinator:
Ann Johnston
678-298-3235

Doctors:

Vasily J. Assikis MD
Minesh D. Patel MD

Piedmont Cancer Institute - Stockbridge


1240 Eagles Landing Parkway
Suite 260
Stockbridge, GA 30281
www.piedmontcancerinstitute.com

Study Coordinator:
Ann Johnston
678-298-3235

Doctors:

Eric D. Mininberg MD
Ha N. Tran MD
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