None listed
Conditions
Brief summary
The purpose of this study is to compare the efficacy of administering the drugs, EPI-7386 and Darolutamide, in combination versus Darolutamide alone, as treatment for patients with prostate cancer, before they undergo standard surgery to remove the prostate gland. Who is it for? You may be eligible for this study if you have been diagnosed with localized prostate cancer and have been referred for radical prostatectomy surgery. Study details Participants will be randomly allocated to either doublet therapy consisting of EPI-7386 and Darolutamide (Arm A) or Darolutamide alone (Arm B) for a treatment duration of 12 weeks. Treatment will be in the form of oral tablets. Prostatectomy will occur the day after completing neoadjuvant therapy, and specimens removed during surgery will then be examined to determine treatment efficacy. It is hoped that information collected in this study will help inform treatment options for patients with localized prostate cancer undergoing removal of their prostate.
Interventions
Patients with high-risk localised prostate cancer will be treated with darolutamide alone or
daroluatmide and EPI-7386 prior to prostatectomy.
Darolutamide:
- oral tablet administration, 600mg twice daily for 12 weeks
EPI-7386:
- oral tablet administration, 300mg twice daily for 12 weeks
Prostatectomy will occur the day after completing the 12 weeks (+/- 14 days) of neoadjuvant therapy.
Patients will be given a diary to help them keep on track with taking the study tablets. The patient diary
Patients with high-risk localised prostate cancer will be treated with darolutamide alone or daroluatmide and EPI-7386 prior to prostatectomy. Darolutamide: - oral tablet administration, 600mg twice daily for 12 weeks EPI-7386: - oral tablet administration, 300mg twice daily for 12 weeks Prostatectomy will occur the day after completing the 12 weeks (+/- 14 days) of neoadjuvant therapy. Patients will be given a diary to help them keep on track with taking the study tablets. The patient diary will be reviewed by the study team during and at the end of the trial. Patients will also be instructed to return all remaining drug and packaging to monitor adherence to the intervention.
Sponsors
St Vincent's Hospital Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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)
Outcome results
None listed