A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing The Efficacy And Safety Of Capivasertib+Abiraterone Versus Placebo+Abiraterone As Treatment For Patients With Denovo Metastatic Hormone-Sensitive Prostate Cancer Characterised By Pte
Posted Date: Oct 19, 2021
- Investigator: Shuchi Gulati
- Specialties:
- Type of Study: Drug
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. There are 2 arms in this study. In arm 1, Participants will receive capivasertib in combination with abiraterone (prednisone/prednisolone) on a background of ADT. In arm 2, Participants will receive placebo in combination with abiraterone (prednisone/prednisolone) on a background of ADT. Efficacy will be determined by Radiographic Progression-free Survival.
Criteria:
Asymptomatic Or Mildly Symptomatic, Histologically-Confirmed De Novo Metastatic Hormone-Sensitive Prostate Adenocarcinoma Without Small-Cell Tumours. A Valid Pten Ihc Result Indicating Pten Deficiency (Centralized Testing). Metastatic Disease Documented Prior To Randomisation By Clear Evidence Of = 1 Bone Lesion And/Or = 1 Soft Tissue Lesion Accurately Assessed At Baseline And Suitable For Repeated Assessment With Ct And/Or Mri. Candidate For Abiraterone And Steroid Therapy. Ongoing Adt With Gnrh Analogue, Or Lhrh Agonists Or Antagonist, Or Bilateral Orchiectomy (Regardless Of Method) Is From 0 Days To A Max. Of 3 Months Prior To Randomisation. (Ecog)/Who Performance Status 0 To 1 With No Deterioration Over The Previous 2 Weeks And Minimum Life Expectancy Of 12 Weeks. 7-Day Brief Pain Inventory-Short Form (Bpi-Sf) And Brief Fatigue Inventory(Bfi) Questionnaires And The Analgesic Diary During Screening Completed. No Radiotherapy With A Wide Field Of Radiation Within 4 Weeks Before The Start Of Study Treatment (Capivasertib/Placebo). No Major Surgery Within 4 Weeks Prior To Start Of Study Treatment. No Brain Metastases, Or Spinal Cord Compression. No Past Medical History Of Interstitial Lung Disease, Drug-Induced Interstitial Lung Disease, Radiation Pneumonitis Which Required Steroid Treatment, Or Any Evidence Of Clinically Active Interstitial Lung Disease. No Evidence Of Dementia, Altered Mental Status, Or Any Psychiatric Condition That Would Prohibit Understanding Or Rendering Of Informed Consent. No Known Additional Malignancy That Has Had Progression Or Has Required Active Treatment In The Last 3 Years. No Drugs Known To Prolong The Qt Interval Within 5 Half-Lives Of The First Dose Of Study Treatment.
Keywords:
Phase 3, Gu, Cancer
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com