Prostate Cancer EA8183 (ERADICATE)

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)

Summary:

To determine whether 12 months (48 weeks) of androgen deprivation therapy (ADT) and darolutamide improves metastasis-free survival (MFS) compared to 12 months (48 weeks) of ADT plus placebo in men with high risk prostate cancer (defined by CAPRA-S score ≥3 and a high Decipher score (>0.6) (C3+D+)) that have undergone radical prostatectomy.

Key Inclusion Criteria:

Step 0-Pre Registration:

• Must have undergone a radical prostatectomy (RP)
• Must be pre-registered to Step 0
  • At a minimum of 2 weeks after RP
  • Not more than 24 weeks (with Decipher score through standard of care testing  outside of protocol), or up to 19 weeks (without Decipher score) after RP
• For patients who have previously had Decipher score through standard of care, score must be > 0.6
• For patients who did not have a Decipher score previously performed, must have a CAPRA-S score ≥ 3 and then can get Decipher testing through the protocol
• Prior or concurrent malignancy within 5 years of registration, whose  natural history or treatment does not have the potential to interfere  with the safety or efficacy assessment of the investigational regimen  are eligible
• No previous treatment with androgen deprivation therapy (ADT),  chemotherapy, or other prostate cancer therapy
• – Prior treatment with bicalutamide is permitted
• No pathologic evidence of pelvic lymph node involvement

Step 1 Randomization

• Must be randomized a minimum of 6 weeks and a maximum of 24 weeks from surgery
• For patients who did not have a Decipher score, they must have had a Decipher score of > 0.6 assessed from the prostatectomy specimen submitted as per Section 10
• Must have an undetectable PSA (< 0.2ng/mL) obtained within 2 weeks prior to  randomization
• Must not have pre or post-operative radiographic evidence of cancer recurrence or  metastasis by abdominal and pelvic imaging (CT abdomen/pelvis, whole body MRI,  MRI abdomen/pelvis, or equivalent, AND bone scan).    Imaging can be done before or  after prostatectomy and within 24 weeks prior to randomization

Primary Study Contact: Sierra Irizarry 860-972-4062

Research procedures may be conducted at the following locations: Hartford Hospital

Non-interventional study visits may take place at the following locations: HHC Medical Group at Avon and Manchester, Hospital of Central Connecticut, Midstate Medical Center