Testing several cancer drugs in men with metastatic prostate cancer
Tests several anti-cancer drugs, including docetaxel, in adults with metastatic prostate cancer.
Plain-language title generated from the registry record
Registry title: Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer
Key facts
- Where
- Bergamo, Meldola, Milan, and Roma, ItalySee the 4 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with metastatic prostate cancer that keeps growing despite hormone-lowering treatment and who have already had a newer hormone-blocking drug.
- Age
- 18 Years to 99 Years
- Sex
- Men only
- Disease stage
- Adenocarcinoma of the prostate that has spread (metastatic) and keeps growing despite castration-level testosterone (progressive metastatic castration-resistant prostate cancer). At least one metastatic lesion that cannot be removed by surgery. Disease that can be measured on scans. ECOG performance status of O or 1. Life expectancy of 3 months or more. Sub study 1: PSMA positive disease on PET scan, with no PSMA negative lesions.
- Earlier treatment
- Must have had at least one novel androgen receptor pathway inhibitor (such as enzalutamide, darolutamide, apalutamide or abiraterone acetate). Must have had orchiectomy and/or be on ongoing androgen deprivation therapy. Sub study 1: only a single line of such a drug, unless more than one was used because of toxicity or intolerance. Sub study 1: no earlier palacaparib (AZD9574) and no more than 1 earlier line of any other PARP inhibitor regimen.
- Biomarker or test result
- Serum testosterone at castrate level (<50ng/dL or <l.7nmol/L). Sub study 1: PSMA positive on PSMA PET scan, with at least 1 PSMA positive metastatic lesion and no PSMA negative lesions.
Main reasons for not taking part
- Small cell, neuroendocrine, sarcomatoid, spindle or signet cell forms of prostate cancer
- History of brain or central nervous system metastases, leptomeningeal carcinomatosis, or spinal cord compression
- Another cancer, interstitial lung disease or non-infectious pneumonitis, or myelodysplastic syndrome or acute myeloid leukaemia
- Active infection, including tuberculosis, hepatitis C or hepatitis B
- Unable to swallow tablets or capsules, or stomach and bowel problems that affect absorption
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07590934, who can take part
Where in Italy
- BergamoHospital not named in the registryNot yet recruiting
- MeldolaHospital not named in the registryNot yet recruiting
- MilanHospital not named in the registryNot yet recruiting
- RomaHospital not named in the registryNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07590934
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell); Minimum life expectancy of 3 months or more; Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration; PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease; Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate; Must have one or more unresectable metastatic lesions; Must have had prior orchiectomy and/or ongoing androgen deprivation therapy, and a castrate level of serum testosterone (<50ng/dL or <l.7nmol/L); Progressive metastatic castration-resistant prostate cancer (mCRPC) following the most recent treatment at time of study entry; Adequate organ and marrow function; 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; 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; 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; Capable of self-administering oral formulations.
Exclusion: Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology ; Concurrent serious medical conditions; Previous history of interstitial lung disease or non-infectious pneumonitis; Persistent toxicities caused by previous therapy; 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); Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous); Participants with a history of central nervous system metastases; Symptomatic malignant spinal cord compression or findings indicative of impending cord compression; Participants with a history of leptomeningeal carcinomatosis; Participants unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with absorption; Active infection, including tuberculosis, hepatitis C virus, and hepatitis B virus infection; Known hypersensitivity to study intervention or any of their excipients; History of uncontrolled seizures or requirement for >2 antiepileptic drugs; History of severe brain injury or stroke; Participants with a history or clinical/laboratory features suggestive of myelodysplastic syndrome or acute myeloid leukaemia; Known, unresolved urinary tract obstruction; Skeletal metastases demonstrating a superscan appearance on bone scan.