Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer
A Phase Ib/II, Open-label, Multi-centre, Platform Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Multiple Anti-Cancer Agents in Metastatic Prostate Cancer
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 to 99 Years
- 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 several cancer drugs in people with prostate cancer that has spread and is getting worse despite treatment to lower testosterone. It looks at safety, side effects, how the body handles the drugs, and how well they may work.
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic 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 adenocarcinoma, a type of cancer confirmed by a tissue test, with spread that can be checked using study rules. At least one area of spread cannot be removed by surgery.
- Be expected to live at least 3 months. Be fully active or able to do light work, with no recent decline in activity.
- Have received at least one newer drug that blocks male hormones, such as enzalutamide or abiraterone.
- Have had surgery to remove the testicles and/or be on treatment to lower male hormones. Testosterone must be below 50 ng/dL, and the cancer must be getting worse after the latest treatment.
- Have organs and bone marrow that work well enough for the study.
- If not sterilized and sexually active with a partner who could get pregnant, use condoms and spermicide if available. Do not father a child or freeze or donate sperm. The partner is also advised to use highly effective birth control.
- For substudy 1: Have had only one course of newer male-hormone-blocking treatment. Switching drugs because of side effects, but not cancer growth, is allowed.
- For substudy 1: Be able to take oral drugs yourself. A special PET/CT scan must show the PSMA marker in all required cancer areas, with at least one area showing more tracer than the liver and no PSMA-negative areas.
Who can't join
- Have another form of prostate cancer, or a past or current separate cancer.
- Have an unresolved blockage in the urinary tract, or cancer pressing on the spinal cord that causes symptoms or may soon cause pressure.
- Have a history of cancer spreading to the brain, spinal cord, or their lining.
- Have another serious medical condition; a history of lung scarring or lung swelling not caused by infection; or signs or a history of myelodysplastic syndrome or acute myeloid leukemia, which affect blood-forming cells.
- Have lasting side effects from past treatment, trouble swallowing drugs, or stomach or bowel problems that could keep drugs from being absorbed.
- Have an active infection, including tuberculosis or hepatitis B or C, or a known allergy to a study drug or its ingredients.
- For substudy 1: Have a history of uncontrolled seizures, need more than two seizure drugs, or have a history of severe brain injury or stroke.
- For substudy 1: Have widespread bone cancer spread that creates a “superscan” pattern on a bone scan, have taken palacaparib (AZD9574), or have had more than one course of treatment using another PARP inhibitor, a type of cancer drug.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell). 2. Minimum life expectancy of 3 months or more. 3. Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration. 4. PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease. 5. Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate. 6. Must have one or more unresectable metastatic lesions. 7. Must have had prior orchiectomy and/or ongoing androgen deprivation therapy, and a castrate level of serum testosterone (\<50ng/dL or \<l.7nmol/L). 8. Progressive metastatic castration-resistant prostate cancer (mCRPC) following the most recent treatment at time of study entry. 9. Adequate organ and marrow function. 10. Non sterilised participants who are sexually active with a partner of childbearing potential must use a condom (plus spermicide, if available), must refrain from fathering a child, freezing or donating sperm, and it is recommended for the partner to also use a highly effective contraceptive method. Inclusion Criteria for Sub study 1: 1. Must have received a single line of ARPI, such as enzalutamide, darolutamide, apalutamide or abiraterone acetate. Participants who were exposed to more than one ARPI due to toxicity or intolerance (not due to disease progression) are eligible. 2. PSMA positive mCRPC by computed tomography positron emission tomography, obtained with PSMA ligand defined as at least 1 PSMA positive metastatic lesion with tracer uptake greater than liver, and no PSMA negative lesions. All measurable or intraprostatic lesions must be PSMA positive. 3. Capable of self-administering oral formulations. Exclusion Criteria: 1. Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous). 2. Known, unresolved urinary tract obstruction. 3. Participants with a history of central nervous system metastases. 4. Symptomatic malignant spinal cord compression or findings indicative of impending cord compression. 5. Participants with a history of leptomeningeal carcinomatosis. 6. Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology . 7. Concurrent serious medical conditions. 8. Previous history of interstitial lung disease or non-infectious pneumonitis. 9. Participants with a history or clinical/laboratory features suggestive of myelodysplastic syndrome or acute myeloid leukaemia. 10. Persistent toxicities caused by previous therapy. 11. Participants unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with absorption. 12. Active infection, including tuberculosis, hepatitis C virus, and hepatitis B virus infection. 13. Known hypersensitivity to study intervention or any of their excipients. Exclusion Criteria for Sub study 1: 1. History of uncontrolled seizures or requirement for \>2 antiepileptic drugs. 2. History of severe brain injury or stroke. 3. Skeletal metastases demonstrating a superscan appearance on bone scan. 4. Participants have received prior therapy with palacaparib (AZD9574) or more than 1 prior line of any other Poly-ADP-ribose polymerase inhibitor (PARPi)-based regimen (either as a treatment or as maintenance).
Study sites (12)
CA
- Research Site · Duarte, CA 91010More trials in Duarte
- Research Site · Encino, CA 91436More trials in Encino
- Research Site · South Pasadena, CA 91030More trials in South Pasadena
FL
- Research Site · Miami, FL 33165More trials in Miami
- Research Site · Orlando, FL 32806More trials in Orlando
- Research Site · Tampa, FL 33612More trials in Tampa
LA
- Research Site · Metairie, LA 70006More trials in Metairie
MN
- Research Site · Minneapolis, MN 55455More trials in Minneapolis
NE
- Research Site · Omaha, NE 68130More trials in Omaha
NY
- Research Site · New York, NY 10065More trials in New York
OR
- Research Site · Portland, OR 97239More trials in Portland
TX
- Research Site · Houston, TX 77030More trials in Houston