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
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.
• 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.