GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy
GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer (CRPC) After Progression on Anti-Androgen Therapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether GZ17-6.02 can slow the worsening of advanced prostate cancer. It is for people whose cancer got worse after treatment to lower male hormones and at least one drug that blocks their action.
The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have prostate cancer that got worse after hormone-lowering treatment and at least one hormone-blocking drug. Past chemotherapy or PSMA-targeted treatment is allowed but not required.
- Have male hormone levels of 50 ng/dL or lower.
- Have rising PSA, a blood marker for prostate cancer, on two tests at least 7 days apart.
- Have cancer that can be measured on a CT scan or checked on a bone scan.
- Be able to care for yourself and be up and about for at least half of your waking hours.
- Meet the study’s liver, kidney, and blood count requirements.
- Agree not to donate blood or sperm during treatment and for 90 days after the last dose. Use highly effective birth control during the study if your partner could become pregnant.
- Be able to understand the study and agree to sign a consent form.
Who can't join
- Recently used an experimental drug, or are in another trial testing a cancer treatment. The required wait depends on how long the experimental drug stays in your body.
- Have PSA of 10 ng/mL or lower at the specified disease stage, along with at least 20 areas of cancer spread in the bones.
- Have small cell, anaplastic, or neuroendocrine cancer types, or active cancer spread to the brain or the tissue covering the brain and spinal cord.
- Have uncontrolled diarrhea causing dehydration or blood salt problems that oral treatment cannot control, or a severe uncontrolled infection.
- Had major surgery within 3 weeks before treatment, or have surgery side effects that have not improved to mild or less.
- Need to keep taking drugs that may interact with study treatment. Most listed drugs must be stopped at least 2 weeks before treatment; MAOI drugs must be stopped 10 days before.
- Cannot swallow medicine, have a known or suspected problem absorbing food or a blockage, or are allergic to study drug ingredients.
- Have active untreated hepatitis B or C, liver scarring, or the listed fatty liver diseases. Other medical, mental health, or social conditions may also rule you out if they raise risk or make study rules hard to follow.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. * Measurable disease by RECIST v1.1 on chest/abdomen/pelvis CT or evaluable disease observed on bone scan. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Appropriate hepatic function defined by a total bilirubin (TBL) ≤1.5 × the upper limit of normal (ULN), alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) ≤3 × ULN at screening. * Appropriate kidney function defined by calculated or actual creatinine clearance ≥30 mL/min * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3. * Platelets ≥100,000 cells/mm3. * Serum hemoglobin level ≥8 g/dL. * Agree to not donate blood or sperm during the study and for 90 days after the last dose of study treatment. * Patients with sexual partners of childbearing potential must agree to use highly effective methods of contraception throughout the study * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Any investigational agent: within 4 weeks OR within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before initiating study treatment. * 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. * Major surgery (in the opinion of the treating investigator) ≤3 weeks before initiating study treatment. * Not having fully recovered to a grade of 1 or lower from any surgery-related adverse effects within the 3 weeks preceding the start of the study treatment. * Small cell, anaplastic, or neuroendocrine component. * Known active brain metastasis. * Known active leptomeningeal disease. * Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment must be discontinued ≥2 weeks prior to initiating study treatment unless otherwise noted: * Monoamine oxidase inhibitors (MAOI) use; must discontinue use 10 days prior to initiating study therapy. * Strong or moderate CYP1A2, CYP3A4 and CYP2C19 inhibitors. * Rucaparib, Olaparib and Talazoparib, due to their common findings of liver enzyme elevation. * Inability to swallow medication. * Known hypersensitivity to GZ17-6.02 components (curcumin, harmine, and isovanillin) or excipients. * Known or suspected malabsorption condition or obstruction. * Active untreated hepatitis B or C" and "Known liver cirrhosis of any cause, active nonalcoholic steatohepatitis, or nonalcoholic fatty liver disease. Note: no additional testing necessary to confirm * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Study sites (1)
VA
- Virginia Commonwealth University · Richmond, VA 23298Massey CTO GU Team · Study contact · 804-628-6430 · masseygu@vcu.eduJohn Melson, MD · Principal investigatorMore trials in Richmond