Metastatic Castration-resistant Prostate Cancer Clinical Trial
— VERACITYOfficial title:
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
NCT number | NCT04844749 |
Other study ID # | V3011102 |
Secondary ID | |
Status | Terminated |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 24, 2021 |
Est. completion date | May 4, 2023 |
Verified date | February 2024 |
Source | Veru Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 105 |
Est. completion date | May 4, 2023 |
Est. primary completion date | May 4, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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 - Creatinine clearance =60 mL/min (using Cockcroft-Gault equation) - Absolute neutrophil count (ANC) =1.5 x 109/L - Platelet count =100 x 109/L - Total bilirubin = upper limit of normal (ULN) (or <2.5 x ULN for patients with known Gilberts disease) - Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT))/Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) =2.5 x ULN. NOTE: Patients with elevations in bilirubin, AST, or ALT should be thoroughly evaluated for the etiology of this abnormality prior to entry and patients with evidence of viral infection should be excluded. Patients with chronic renal stent and stable creatinine elevation can be included in the study with written documentation from the PI. - Participants must have a life expectancy >3 months. - Subjects must agree to use acceptable methods of contraception: - If the study subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e.,barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository). - If female partner of a study subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)should also be used.-If female partner of a study subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS),a barrier method (condom with spermicidal foam/gel/film/cream/suppository)should also be used. - Other than metastatic prostate cancer, no evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin or other cancers treated with curative intent >3 years prior). - Participants must agree to refrain from prolonged exposure to the sun or agree to use at least SPF 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with VERU- 111. - Subject is willing to comply with the requirements of the protocol through the end of the study. Exclusion Criteria: - 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. - Patients should be excluded if they have had prior systemic treatment with prior taxane chemotherapies (for greater than 2 cycles) for advanced prostate cancer. Patient can have up to 2 cycles of prior taxane chemotherapy greater than one year prior to randomization and remain eligible for inclusion in this study. Taxane exposure in the adjuvant or neoadjuvant setting is allowed (maximum of 6 cycles). - 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. - Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous. Active infections discovered during screening period must be treated and controlled before patient is dosed with VERU-111. - Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia. - Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease, or any psychiatric disorder that prohibits obtaining informed consent. - Total bilirubin levels > 1.5 x ULN (>2.5 x ULN in patients with known Gilbert's disease). - AST and/or ALT levels >2.5xULN or AST and/or ALT levels >1.5xULN WITH concomitant alkaline phosphatase levels >2.5xULN. |
Country | Name | City | State |
---|---|---|---|
United States | Alaska Oncology and Hematology, LLC. | Anchorage | Alaska |
United States | Georgia Urology | Atlanta | Georgia |
United States | Centers for Advanced Urology, LLP MidLantic Urology | Bala-Cynwyd | Pennsylvania |
United States | Chesapeake Urology Research Associates | Baltimore | Maryland |
United States | Ascension - Our Lady of Lourdes Memorial Hospital | Binghamton | New York |
United States | University of Virginia Health System | Charlottesville | Virginia |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Universal Axon Clinical Research | Doral | Florida |
United States | Colorado Urology | Golden | Colorado |
United States | Houston Metro Urology | Houston | Texas |
United States | First Urology, PSC | Jeffersonville | Indiana |
United States | Comprehensive Urologic Care | Lake Barrington | Illinois |
United States | Tower Urology | Los Angeles | California |
United States | MidAmerica Cancer Care | Merriam | Kansas |
United States | Demirra Hudge | Miami Beach | Florida |
United States | Clinical Research Solutions - Cleveland | Middleburg Heights | Ohio |
United States | Inpsira Medical Center Mullica Hill | Mullica Hill | New Jersey |
United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
United States | Urology Associates - Nashville | Nashville | Tennessee |
United States | GU Research Network, LLC | Omaha | Nebraska |
United States | University of California, Irvine | Orange | California |
United States | West Coaster Center Urology | Oxnard | California |
United States | Premier Medical Group of the Hudson Valley | Poughkeepsie | New York |
United States | Associated Urologists of North Carolina | Raleigh | North Carolina |
United States | Virginia Urology | Richmond | Virginia |
United States | Florida Urology Partners, LLC | Riverview | Florida |
United States | Urology San Antonio P.A. | San Antonio | Texas |
United States | San Bernardino Urological Associates | San Bernardino | California |
United States | Genesis Resaerch, LLC | San Diego | California |
United States | Genesis Healthcare Partners - Genesis Research Greater Los Angeles | Sherman Oaks | California |
United States | Spokane Urology P.S. | Spokane | Washington |
United States | Cancer Care Northwest | Spokane Valley | Washington |
United States | Oregon Urology Institute | Springfield | Oregon |
United States | Associated Medical Professionals of NY, PLCC | Syracuse | New York |
United States | Alicia Buenrostro | Torrance | California |
United States | Michigan Institute of Urology | Troy | Michigan |
United States | Arizona Urology Specialists | Tucson | Arizona |
United States | Urology Associates of Southern Arizona | Tucson | Arizona |
United States | Urology of Virginia, PLLC | Virginia Beach | Virginia |
United States | Lexington Medical Center/ Lexington Oncology | West Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Veru Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall Survival | Overall survival (OS) will be an assessment of time from randomization into the study to all-cause mortality. The analysis will be performed similarly to the primary endpoint. | 360 days |
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