A Phase III Double Blinded Study of Early Intervention after RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE)

Protocol # :
Prostate Carcinoma
Disease Sites
Principal Investigator
Morgans, Alicia, K
Site Research Nurses
Bretta, Katherine, v.
Leisner, Claire
Mingrino, Sage
Prisby, Judith

Trial Description

This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after
surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in
the blood. Testosterone is a hormone made mainly in the testes and is needed to develop and
maintain male sex characteristics, such as facial hair, deep voice, and muscle growth. It
also plays role in prostate cancer development. Darolutamide blocks the actions of the
androgens (e.g. testosterone) in the tumor cells and in the body. Giving darolutamide with
ADT may work better in eliminating or reducing the size of the cancer and/or prevent it from
returning compared to ADT alone in patients with prostate cancer.

Eligibility Requirements

Inclusion Criteria:


- Patient must have undergone a radical prostatectomy (RP) and must be registered to
step 0 of this study at least 6 weeks after but not more than 16 weeks after their
radical prostatectomy

- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0- 2

- Patient with a 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 for this trial

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated

- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load

- For patients with no previous Decipher score: Tumor tissue specimen from prostatectomy
must be available and ready to be shipped


- For patients who have previously had Decipher score performed by Decipher Biosciences,
they must have score of >= 0.6

- For patients who did not have a Decipher score previously performed by Decipher
Biosciences, they must have had a Decipher score of >= 0.6 assessed from the
prostatectomy specimen submitted

- For patients who did not have a Decipher score previously performed by Decipher
Biosciences, patients must also have a CAPRA-S score >= 3. The CAPRA-S score is
calculated by assigning points for PSA in ng/mL, surgical margin status, seminal
vesicle invasion, and extra-capsular extension. Lymph node involvement will serve as
an exclusion criteria and will not count towards CAPRA-S inclusion score. A CAPRA-S
score is not required for patients who had a Decipher score previously performed by
Decipher Biosciences

- Patient must have an undetectable PSA (< 0.2ng/mL) obtained within 2 weeks prior to

- Leukocytes >= 3,000/mcL (obtained within 4 weeks prior to registration)

- Absolute neutrophil count >= 1,000/mcL (obtained within 4 weeks prior to registration)

- Platelets >= 75,000/mcL (obtained within 4 weeks prior to registration)

- Total bilirubin =< institutional upper limit of normal (ULN) (obtained within 4 weeks
prior to registration)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 x institutional ULN (obtained within 4 weeks prior to registration)

- Glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2 (obtained within 4 weeks prior
to registration)

Exclusion Criteria:


- Patient must not have any previous treatment with androgen deprivation therapy (ADT),
chemotherapy, or other physician prescribed systemic therapy for treatment of their
prostate cancer

- Patient must not have pathologic evidence of pelvic lymph node involvement

- Patient must not have an uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure (New York Heart
Association class III and IV heart failure), unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements


- Patient must not have pre or post-operative radiographic evidence of cancer recurrence
or metastasis by abdominal and pelvic imaging (computed tomography [CT]
abdomen/pelvis, whole body magnetic resonance imaging [MRI], MRI abdomen/pelvis, or
equivalent, AND bone scan) which must be done before or after prostatectomy prior to
randomization. If pre-operative risk does not indicate a need for bone scan,
post-operative Decipher score of >= 0.6 indicates increased risk of metastatic disease
and may be used to obtain CT abdomen/pelvis and bone scan prior to randomization