Ea8183 A Phase III Double Blinded Study Of Early Intervention After Radical Prostatectomy With Androgen Deprivation Therapy With Or Without Darolutamide Vs. Placebo In Men At Highest Risk Of Prostate Cancer Metastasis By Genomic Stratification (Eradicate)
Posted Date: Jul 6, 2021
- Investigator: Abhinav Sidana
- Specialties: Cancer, Oncology, Prostate Cancer
- Type of Study: Drug
The primary objective of this study is to compare the effect of adding daroluatamide to ADT versus ADT alone after surgery for the treatment of high risk prostate cancer. The primary outcome measure is metastasis free survival. Patients in arm A will receive a placebo four times daily for 52 weeks, and will receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients in arm B will receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months, every 4 months for 12 months, or every month for 12 months in the absence of disease progression or unacceptable toxicity, and will receive darolutamide QID for 52 weeks.
Participants Must Have Ecog Score Of 0-2, Participants With A Prior Or Concurrent Malignancy Within 5 Years Of Registration, Participants Must Have A Decipher Score Of >=0.6, Patient Must Have An Undetectable Psa (< 0.2Ng/Ml) Obtained Within 2 Weeks Prior To Randomization, Leukocytes Must Be >= 3,000/Mcl, Absolute Neutrophil Count Must Be >= 1,000/Mcl, Platelets Must Be >= 75,000/Mcl, Gfr Must Be >= 30 Ml/Min/1.73 M^2. No Previous Treatment With Androgen Deprivation Therapy (Adt), Chemotherapy, Or Other Physician Prescribed Systemic Therapy For Treatment Of Their Prostate Cancer, No Pathologic Evidence Of Pelvic Lymph Node Involvement, No Uncontrolled Intercurrent Illness.
For More Information:
Uc Cancer Center