FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate… (NCT06909825) | Clinical Trial Compass
Active — Not RecruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Australia85 participantsStarted 2025-02-26
Plain-language summary
This study is an open-label, multicenter study designed to investigate the efficacy, safety and tolerability of FPI-2265 (225Ac-PSMA-I\&T) in combination with Olaparib in participants with mCRPC. The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 and Olaparib in participants with metastatic castration-resistant prostate cancer.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult male participants with mCRPC that is progressing at the time of study entry
. ECOG performance status 0-1 and life expectancy of at least three months
. Must have received at least one novel anti-androgen deprivation therapy
. Participants with known BRCA mutations should have received approved therapies such as PARP inhibitors, per Investigator discretion.
. All prior treatment-related AEs must have resolved to CTCAE Grade ≤1 (except alopecia).
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate anti-tumour activity of FPI-2265 administered in combination with olaparib
Timeframe: From first dose until approximately 12 weeks after the first administered dose of FPI-2265
2
Evaluate the safety and tolerability of FPI-2265 administered in combination with olaparib
Timeframe: From first dose until end of long-term follow-up, 5 years from the last administered dose of FPI-2265
. Participants must have adequate organ and bone marrow function:
Exclusion criteria
. Previous treatment with any of the following within 6 months of first dose: Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation.
. Participants who received more than two (2) prior lines of cytotoxic chemotherapy for CRPC.
. Participants with known unresolved urinary tract obstruction.
. Transfusion- or growth factor-dependent participants.
. 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.
. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
. Participants with any liver metastases.
. Participants with skeletal metastases presenting as a superscan .