A Multicenter, Randomized, Controlled Phase 2 Study: Efficacy and Safety of I-131-1095 Radiotherapy in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Who Are 18F-DCFPyL Prostate-specific Membrane Antigen (PSMA)-Avid, Chemotherapy-naive, and Progressed on Abiraterone

Who is this study for? Adult patients with metastatic castration-resistant prostate cancer
What treatments are being studied? I-131-1095+Enzalutamide
Status: Active, not recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2

This is a multicenter, randomized, controlled, phase 2 clinical trial designed to evaluate the safety and efficacy of I-131-1095 radiotherapy in combination with enzalutamide compared to enzalutamide alone in participants with prostate-specific membrane antigen (PSMA)-avid metastatic castration resistant prostate cancer (mCRPC) who have progressed on abiraterone. Participants must be chemotherapy-naive and must be ineligible or refuse to receive taxane-based chemotherapy at time of study entry. PSMA-avidity will be determined by central imaging review based on assessment of 18F-DCFPyL PET/CT imaging during screening. Eligible participants meeting the PSMA-avidity criteria will be randomized in a 2:1 ratio to receive either I-131-1095 in combination with enzalutamide (80 participants) or enzalutamide alone (40 participants). An interim analysis for efficacy will be performed after a minimum of 48 evaluable participants have PSA data for at least three months following the first dose of randomized treatment. All participants will be followed for efficacy, safety assessments, survival status, adverse events of special interest, and new anti-cancer therapy for at least one year or to the end of the study (whichever is later) following the first dose of randomized treatment. Safety data will be monitored by an independent Data Monitoring Committee and the sponsor.

Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: No

• Male ≥ 18 years of age

• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features at initial diagnosis

• Castration-resistant prostate cancer, with serum testosterone ≤ 50 ng/dL at Screening

• Radiographic evidence of metastatic disease prior to Randomization or up to 21 days prior to Screening

• Disease progression on prior abiraterone therapy as defined by meeting at least one of the following criteria per the investigator:

• PSA progression as defined by a minimum of two rising PSA levels at least 1 week apart

• Soft tissue disease progression defined by RECIST 1.1

• Bone disease progression defined by two or more new lesions on bone scan

• Planned to receive treatment with enzalutamide

• Subjects who are ineligible or choose not to receive taxane-based chemotherapy based on personal preference or physician opinion. Examples of conditions that could make a patient ineligible or refuse to receive taxane-based chemotherapy, but would allow them to still be eligible to receive I-131-1095 include the following:

• Poor performance status

• Prior intolerance to cytotoxic agents

• History of another malignancy suspected for recurrence or metastases

• Other serious medical conditions such as symptomatic peripheral neuropathy CTCAE Grade 2 or higher; or clinically significant cardiovascular disease per the Investigator or treating physician

• Subjects receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks prior to Randomization

• ECOG performance status 0-2

• If sexually active, agree to use a medically acceptable method of birth control or sexual abstinence from the time of dosing through 28 days after the last dose of I-131-1095. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.

• Estimated life expectancy of at least 6 months as determined by the Investigator.

• Able and willing to provide signed informed consent and comply with protocol requirements

United States
City of Hope
Los Angeles
VA Greater Los Angeles Healthcare System
Los Angeles
Hoag Family Cancer Institute
Newport Beach
VA Palo Alto Healthcare System
Palo Alto
Washington, D.c.
Medstar Georgetown University Hospital
University of Iowa
Iowa City
The University of Chicago
Tulane Medical School
New Orleans
University of Maryland
University of Michigan Comprehensive Cancer Center
Ann Arbor
Washington University School of Medicine
Saint Louis
New York
SUNY Upstate Medical University
University of Pennsylvania
Rhode Island
LifeSpan Cancer Institute
South Carolina
Medical University of South Carolina
University of Texas MD Anderson Cancer Center
University of Virginia Cancer Center
University of Washington - Seattle Cancer Care Alliance
Virginia Mason Medical Center
Other Locations
Centre Hospitalier Del' Universite de Montreal
Jewish General Hospital
The Ottawa Hospital
Centre Hospitalier Universitaire de Quebec
Quebec City
Centre Hospitalier Universitaire de Sherbrooke
London Health Sciences Centre
University Health Network - Princess Margaret Cancer Centre
Time Frame
Start Date: May 30, 2019
Estimated Completion Date: June 2024
Target number of participants: 120
Active Comparator: Enzalutamide
Experimental: I-131-1095 in combination with enzalutamide
Related Therapeutic Areas
Leads: Progenics Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov

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