A Randomized, Open-Label, Phase 2 Study of Darolutamide as Single Agent or in Combination with EPI-7386 as a Neoadjuvant Treatment for Patients Undergoing Prostatectomy for Localized Prostate Cancer (DaSCENT)

Phase 2

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12623000160639
• Lead Sponsor: St Vincent's Hospital Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-16
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

1. Willing and able to provide informed consent;
2. Men greater than or equal to 18 years of age;
3. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with a 5 yr progression free probability of less than 80% as per the MSKCC calculator (https://www.mskcc.org/nomograms/prostate/pre_op);
4. Must be candidates for radical prostatectomy and considered surgically resectable by urologic evaluation;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
6. No evidence of metastatic disease outside the pelvis as determined by radionuclide bone scans and computed tomography/magnetic resonance imaging OR PSMA-PET scan;
7. Able to swallow the study drug(s) as prescribed and comply with study requirements;
8. Archived prostate biopsy tissue sample available or willing to undergo fresh biopsy.

Exclusion Criteria

1. Received an investigational agent within 4 weeks prior to randomization;
2. Stage T4 prostate cancer by clinical examination or radiologic evaluation;
3. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone below the normal range for the institution;
4. Prior androgen deprivation, anti-androgen, chemotherapy, surgery, or radiation for prostate cancer;
5. Receiving concurrent androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to randomization;
6. History of another malignancy within the previous 2 years other than curatively treated non-melanomatous skin cancer, superficial bladder cancer or other cancers unlikely to affect study outcomes;
7. Uncontrolled intercurrent illness, including, but not limited to, active infection or deep venous thrombosis within 3 months prior to randomization;
8. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
9. Unwilling to use contraceptives while on study and for 3 months after study (subjects are required to use barrier protection with sexual partners);
10. Any of the following laboratory values obtained within 14 days prior to randomization:
Absolute neutrophil count < 1500/µL, platelet count < 100,000/µL, or hemoglobin < 10 g/dL) (patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the Screening visit)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete pathological response rate at prostatectomy following treatment with combination of EPI-7386 + Darolutamide, or Darolutamide alone for 12 weeks. Assessed on the pathological specimen obtained from prostatectomy.[Time of prostatectomy. - the day after completing neoadjuvant therapy.]