New drug combo shows promise for Tough-to-Treat prostate cancer
NCT ID NCT06909825
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times
Summary
This study tests a new drug combination (FPI-2265 and olaparib) in 85 men with advanced prostate cancer that no longer responds to standard hormone therapy. The goal is to see if the treatment can shrink tumors or lower PSA levels by at least 50%. Participants must have tried at least one prior anti-androgen therapy and be in relatively good health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult male participants with mCRPC that is progressing at the time of study entry 2. ECOG performance status 0-1 and life expectancy of at least three months 3. Must have received at least one novel anti-androgen deprivation therapy 4. Participants with known BRCA mutations should have received approved therapies such as PARP inhibitors, per Investigator discretion. 5. All prior treatment-related AEs must have resolved to CTCAE Grade ≤1 (except alopecia). 6. Participants must have had prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L) 7. Positive PSMA PET/CT scans . 8. Participants must have adequate organ and bone marrow function: * Hgb \>/= 9g/dL * Platelets \>/= 100 x 10\^9/L * ANC \</= 1.5 x 10\^9/L * CrCL \>/= 50 mL/min Exclusion Criteria: 1. Previous treatment with any of the following within 6 months of first dose: Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. 2. Participants who received more than two (2) prior lines of cytotoxic chemotherapy for CRPC. 3. Participants with known unresolved urinary tract obstruction. 4. Transfusion- or growth factor-dependent participants. 5. Participants with a history of CNS metastases are excluded, except those who have received therapy (and are neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. 6. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 7. Participants with any liver metastases. 8. Participants with skeletal metastases presenting as a superscan . 9. Previous history of interstitial lung disease or non-infectious pneumonitis. 10. Participants with a history or clinical and/or laboratory features suggestive of MDS/AML. 11. Major surgery ≤28 days prior to the first dose of study treatment. 12. Planning to conceive a pregnancy during the treatment and up to six months after the last treatment. 13. Participants unable to swallow orally administered medications or with malabsorptive gastrointestinal disorders. 14. Concomitant use of known strong or moderate CYP3A inhibitors or inducers
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, 5037, Australia
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Macquarie University Hospital
Macquarie Park, New South Wales, 2113, Australia
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Peter MacCallum Cancer Center
Melbourne, Victoria, 3000, Australia
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Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?
- Can a smart radiation drug hunt down prostate cancer cells?
- Can a new daily pill slow advanced prostate cancer?