Study Stopped
Administrative reasons
Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent
VERACITY
VERACITY - Randomized, Active-Controlled, Phase 3 Study of VERU-111 for the Treatment of Metastatic Castration-Resistant Prostate Cancer in Patients Who Have Failed Prior Treatment With at Least One Androgen Receptor Targeting Agent
1 other identifier
interventional
105
1 country
40
Brief Summary
To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured by radiographic progression-free survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2021
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 14, 2021
CompletedStudy Start
First participant enrolled
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2023
CompletedFebruary 5, 2024
February 1, 2024
1.9 years
April 9, 2021
February 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of VERU-111 in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent
Radiographic progression-free survival (rPFS) centrally read, which is death or tumor progression as defined by RECIST 1.1 (soft tissue) and PCWG3 (bone).
360 days
Secondary Outcomes (1)
Overall Survival
360 days
Study Arms (2)
Either VERU-111 32mg or 26mg dose will be supplied as capsules 1 orally once a day
EXPERIMENTAL32mg of VERU-111 26mg of VERU-11
Active control alternative androgen receptor targeting agent
ACTIVE COMPARATORThe alternative androgen receptor targeting agent will be administered according to the dosing instructions in the current product prescribing information.
Interventions
Based on the safety and antitumor activity of VERU-111 in the Phase 1b/2 clinical study, VERU-111 is initiating this Phase 3 clinical study of VERU-111 for the treatment of metastatic castration resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent
Enzalutamide and abiraterone were chosen as active comparators are both are FDA approved for the treatment of metastatic castration resistant prostate cancer
Eligibility Criteria
You may qualify if:
- Provide informed consent.
- Be able to communicate effectively with the study personnel.
- Aged ≥18 years.
- Histological or cytologic proof of adenocarcinoma of the prostate not including the diagnosis of small cell carcinoma of the prostate of neuroendocrine pathology.
- Radiographic evidence of metastatic disease at baseline by CT scan, or MRI and bone scan, with confirmation of measurable disease by RECIST 1.1 and/or identifiable discrete bone metastases by PCWG3.
- Known castration resistant prostate cancer, defined according to PCWG3 criteria.
- Have received at least one androgen receptor targeting agent (e.g. abiraterone, enzalutamide, darolutamide, or apalutamide).
- Subjects who have metastatic castration resistant prostate cancer that have maintained or have previously been treated with ADT (while on-study, patients must receive continuous ADT. Either chemical or surgical castration by bilateral orchiectomy is acceptable) and have failed prior treatment with at least one androgen receptor targeting agent (e.g. abiraterone, enzalutamide, darolutamide, or apalutamide) defined as:
- Serum PSA progression of two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 2 weeks apart. Or
- Documented bone lesions by the appearance of two or more new lesions on bone scintigraphy or bi-dimensionally-measurable soft tissue metastatic lesion assessed by CT or MRI.
- Treatment with an alternative androgen receptor targeting agent is a reasonable next line of therapy.
- Absolute PSA ≥2.0 ng/ml at screening.
- ECOG performance status \<2.
- Participants must have normal organ and bone marrow function measured within 30 days prior to administration of study treatment as defined below:
- Hemoglobin ≥9.0 g/dL with no blood transfusion in the past 30 days
- +12 more criteria
You may not qualify if:
- Known hypersensitivity or allergy to colchicine.
- Histologic identification of small cell carcinoma of the prostate or neuroendocrine pathology in either biopsy or prostatectomy tissue.
- A bone scan with evidence of superscan or superscan phenomenon, defined as:
- Uptake throughout the axial skeleton and proximal appendicular skeleton, often somewhat heterogeneous, or,
- Symmetrically intense and diffuse radiotracer uptake in the skeleton with absent or diminished visualization of the genitourinary system and soft tissues, or,
- Defined in the bone scan report as a superscan or superscan phenomenon. NOTE: Medical Monitor should be consulted prior to screening of a patient if a superscan or superscan phenomenon is suspected or possible, but undetermined by any of the above definitions.
- Has received external-beam radiotherapy within the last 2 weeks prior to start of study treatment.
- Patients with a QT interval corrected by Fridericia's formula of \>480 ms.
- Patients receiving full dose warfarin therapy are not eligible for study.
- Patients with prior history of a thromboembolic event within the last 6 months.
- Participation in another clinical study with an investigational product during the last 6 months prior to randomization into this study.
- Any treatment modalities involving major surgery within 4weeks prior to the start of study treatment.
- Patients are excluded if they have known brain metastases or leptomeningeal metastases.
- Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- Has imminent or established spinal cord compression based on clinical findings and/or MRI.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Veru Inc.lead
Study Sites (40)
Alaska Oncology and Hematology, LLC.
Anchorage, Alaska, 99508, United States
Urology Associates of Southern Arizona
Tucson, Arizona, 85715, United States
Arizona Urology Specialists
Tucson, Arizona, 85745, United States
Tower Urology
Los Angeles, California, 90048, United States
University of California, Irvine
Orange, California, 92868, United States
West Coaster Center Urology
Oxnard, California, 93036, United States
San Bernardino Urological Associates
San Bernardino, California, 92506, United States
Genesis Resaerch, LLC
San Diego, California, 92123, United States
Genesis Healthcare Partners - Genesis Research Greater Los Angeles
Sherman Oaks, California, 91411, United States
Alicia Buenrostro
Torrance, California, 90505, United States
Colorado Urology
Golden, Colorado, 80401, United States
Universal Axon Clinical Research
Doral, Florida, 33166, United States
Demirra Hudge
Miami Beach, Florida, 33140, United States
Florida Urology Partners, LLC
Riverview, Florida, 33578, United States
Georgia Urology
Atlanta, Georgia, 30309, United States
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010, United States
First Urology, PSC
Jeffersonville, Indiana, 47130, United States
MidAmerica Cancer Care
Merriam, Kansas, 66204, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, 21204, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
GU Research Network, LLC
Omaha, Nebraska, 68130, United States
Inpsira Medical Center Mullica Hill
Mullica Hill, New Jersey, 08062, United States
Ascension - Our Lady of Lourdes Memorial Hospital
Binghamton, New York, 13905, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12603, United States
Associated Medical Professionals of NY, PLCC
Syracuse, New York, 13210, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Clinical Research Solutions - Cleveland
Middleburg Heights, Ohio, 44130, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Centers for Advanced Urology, LLP MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Lexington Medical Center/ Lexington Oncology
West Columbia, South Carolina, 29169, United States
Urology Associates - Nashville
Nashville, Tennessee, 37209, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Urology San Antonio P.A.
San Antonio, Texas, 78258, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Virginia Urology
Richmond, Virginia, 23230, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
Spokane Urology P.S.
Spokane, Washington, 99202, United States
Cancer Care Northwest
Spokane Valley, Washington, 99216, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Barnette
Veru Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Central reader for scans will be blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2021
First Posted
April 14, 2021
Study Start
June 24, 2021
Primary Completion
May 4, 2023
Study Completion
May 4, 2023
Last Updated
February 5, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share