Ea8191 Phase III Study Of Local Or Systemic Therapy Intensification Directed By Pet In Prostate Cancer Patients With Post-Prostatectomy Biochemical Recurrence (Indicate).
Posted Date: Nov 16, 2021
- Investigator: Abhinav Sidana
- Specialties: Cancer, Oncology, Prostate Cancer
- Type of Study: Drug
This phase III trial will compare the addition of apalutamide, with or without targeted radiation therapy, to standard of care treatment versus standard of care treatment alone in patients with prostate cancer biochemical recurrence (a rise in the blood level of prostate-specific antigen [PSA] after treatment with surgery or radiation). This study will consist of 4 different arms. Efficacy will be determined by progression-free survival (PFS), PFS prolongation in patients without positron emission tomography (PET)-evidence of extrapelvic metastases, and PFS prolongation in patients with PET-evidence of extrapelvic metastases.
Criteria:
Patient Must Have Had A Radical Prostatectomy (Rp) As Definitive Therapy For Histopathologically-Proven Prostatic Adenocarcinoma. Patient Must Be Negative Or Equivocal For Extrapelvic Metastatic Disease By Conventional Imaging Modalities (Cim) (I.E., Bone Scans, Pelvic Ct, Or Pelvic Mri), Which Must Be Done Within 10-12 Weeks Prior To Registration. Patient Must Be A Candidate For Standard-Of-Care (Soc) Post-Prostatectomy Radiation Therapy (Rt) To The Prostate Bed And Pelvic Nodes With Androgen Deprivation Therapy (Adjuvant). Patient Must Have An Eastern Cooperative Oncology Group (Ecog) Performance Status 0-2. Leukocytes >= 3,000/Mcl. Absolute Neutrophil Count >= 1,500/Mcl. Platelets >= 100,000/Mcl. Total Bilirubin =< Institutional Upper Limit Of Normal (Uln). Aspartate Aminotransferase (Ast) (Serum Glutamic Oxaloacetic Transaminase [Sgot])/Alanine Aminotransferase (Alt) (Serum Glutamate Pyruvate Transaminase [Sgpt]) =< 2.5 X Institutional Uln. Glomerular Filtration Rate (Gfr) > 35 Ml/Min Estimated By Cockcroft-Gault Or Measured Directly By 24 Hour Urine Creatinine. Patient Must Not Have Started Androgen Deprivation Therapy For Biochemical Recurrence Prior To Baseline Study Pet/Ct Imaging. Patient Must Not Be Enrolled In Another Therapeutic Clinical Trial. Patient Must Not Have Any Other Malignancy Within The Last 2 Years, Other Than Superficial Bladder Cancer And Skin Basal Cell Carcinoma Or Cutaneous Superficial Squamous Cell Carcinoma That Has Not Metastasized. Patient Must Not Have History Of Seizures Or Known Condition That May Cause Predisposal To Seizures (E.G., Stroke Or Head Trauma Resulting In Loss Of Consciousness) Within 1 Year Of Registration. Patient Must Not Have History Of Inflammatory Bowel Disease As This Would Increase Risk Of Complication From Radiotherapy Or Any Gastrointestinal Disorder Affecting Absorption. Patient Must Not Have Had Prior Radiation Therapy.
Keywords:
Prostate Cancer, Cancer, Pet
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com