Last updated 16 months ago

A Phase 2 Trial of Darolutamide as a Prostate-Specific Membrane Antigen (PSMA) Expression Enhancer in Patients With Localized Prostate Cancer

19 patients around the world

Available in Brazil

D'Or Institute for Research and Education

1Research sites

19Patients around the world

This study is for people with

Prostate cancer

From 18 Years

Male

: To be included in this study, patients should complete all screening procedures and meet all of the following criteria:
Males 18 years of age and above
Histologically or cytologically proven diagnosis of prostate adenocarcinoma
High-risk disease defined as at least one of the following factors:
Gleason ≥8
PSA ≥20 ng/mL
T3/T4 disease
ECOG Performance status of 0 or 1 (Appendix A: Performance Status Criteria)
Patients deemed appropriate candidates for radical prostatectomy
Baseline blood pressure <160 x 100 mmHg
Normal hematologic, liver, and renal functions
Absence of any contraindications for darolutamide use
Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
Baseline testosterone of 200 ng/dL or more
Normal organ function with acceptable initial laboratory values within 14 days of treatment start: Match lab values to those scheduled in Table 1.
ANC • > 1,500/µl
Hemoglobin • > 9g/dL
Platelet count • > 100,000/µl
Creatinine • ≤ 1.5 x the institutional upper limit of normal (ULN)
Potassium • > 3.5 mmol/L (within institutional normal range)
Bilirubin • ≤ ULN (unless documented Gilbert's disease)
SGOT (AST) • ≤ 2.5 x ULN
SGPT (ALT) • ≤ 2.5 x ULN

: Metastatic disease defined by standard scans (bone scans, magnetic resonance, or CT scans)
Any prior or current treatment for prostate cancer
Concomitant treatment with another systemic antineoplastic therapy or another investigational product is prohibited, as follows:
Any investigational product
Radiopharmaceuticals
Immunotherapy (e.g. sipuleucel-T)
Prior orchiectomy or any LHRH agonist or antagonist
Cytotoxic chemotherapy
Enzalutamide, apalutamide, bicalutamide, flutamide, nilutamide
Estrogens
Cyproterone acetate
5-alpha-reductase inhibitors
Abiraterone acetate, TAK-700 or other CYP17 inhibitors
Systemic ketoconazole
Any drug listed in Appendix C
Patients on current treatment for a second malignancy (except for Ta bladder urothelial carcinoma or non-melanoma skin cancer).
Uncontrolled hypertension (defined as systolic blood pressure of 150 mmHg or higher; diastolic blood pressure of 100 mmHg or higher in 2 or more measurements) or uncompensated cardiac disease (NYHA III or IV)
Known allergy, hypersensitivity, any other contraindications to the compounds under investigation (darolutamide or PSMA radiotracers)

Instituto D'Or de Pesquisa e Ensino - Sao Paulo

Recruiting

Av. República do Líbano, 611 - Ibirapuera, São Paulo - SP, 04501-000

SponsorD'Or Institute for Research and Education

Conditions

Prostate cancer

Requirements

From 18 YearsMale

Unique study IDclinicaltrials.gov

NCT05900973