Using Darolutamide to Enhance PSMA Expression in Localized Prostate Cancer
A Phase 2 Trial of Darolutamide as a Prostate-Specific Membrane Antigen (PSMA) Expression Enhancer in Patients With Localized Prostate Cancer
This study is testing if the medication Darolutamide can help improve the detection and treatment of localized prostate cancer in high-risk men before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | D'Or Institute for Research and Education Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT05900973 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Darolutamide, an oral medication, to enhance prostate-specific membrane antigen (PSMA) expression in men diagnosed with localized prostate cancer. The study focuses on high-risk patients, defined by specific criteria such as Gleason scores and PSA levels, who are candidates for radical prostatectomy. Participants will undergo screening to ensure they meet eligibility requirements, including normal organ function and performance status. The goal is to improve the detection and treatment outcomes for prostate cancer through enhanced PSMA expression.
Who should consider this trial
Good fit: Ideal candidates for this study are males aged 18 and older with high-risk localized prostate adenocarcinoma.
Not a fit: Patients with low-risk prostate cancer or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved detection and treatment options for patients with localized prostate cancer.
How similar studies have performed: Other studies have shown promise in enhancing PSMA expression for improved prostate cancer detection, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 Exclusion Criteria * 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)
Where this trial is running
São Paulo
- Instituto D'Or de Pesquisa e Ensino — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: José Mauricio SC Mota, phD — Instituto D'Or de Pesquisa e Ensino (IDOR), São Paulo, Brazil
- Study coordinator: José Mauricio SC Mota, MD, PhD
- Email: jose.cmota@oncologiador.com.br
- Phone: +551121098855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.