GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy
ConditionCastration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorVirginia Commonwealth University
About this trial
The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.
Eligibility criteria
Qualifiers
Patients diagnosed with prostate cancer and treated with androgen deprivation therapy (ADT) and at least one androgen receptor pathway inhibitor (ARPI) (eg, abiraterone, enzalutamide, apalutamide or darolutamide). Previous prostate-specific membrane antigen (PSMA)-targeted therapy or cytotoxic chemotherapy is allowed but not required.
Androgen levels ≤50 ng/dL (≤1.73 nmol/L).
Disease progression following ADT and ARPI treatment described
PSA progression over 2 assessments, defined as rising PSA values from 2 consecutive assessments with an interval of at least 7 days between assessments. PSA levels prior to study enrollment are considered and appropriate for inclusion.
Disqualifiers
Low PSA (≤10 ng/mL) at initial presentation (before ADT or at symptomatic progression in the castrate setting) plus high volume (≥20) bone metastases.
Simultaneous enrollment in any other cancer treatment interventional clinical trial.
Active, uncontrolled diarrhea leading to dehydration or electrolyte disturbances not controlled with oral repletion.
Grade ≥3 uncontrolled infection.
Trial design
Treatments tested in this trial
- Investigational Agent Administration
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov