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New drug combo shows promise for Tough-to-Treat prostate cancer

NCT ID NCT06909825

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 85 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

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

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, South Australia, 5037, Australia

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2113, Australia

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

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