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Radioisotope Therapy

225Ac-PSMA-Trillium for Advanced Prostate Cancer (PAnTHA Trial)

Phase 1

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented progressive mCRPC per PCWG3 criteria

Participants on a stable dose of anticoagulation therapy

Must not have

Prior radiopharmaceutical treatment using 225Ac

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 weeks or later (up to 18 months after end of treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new treatment for men with advanced prostate cancer that has spread to other parts of the body and does not respond to hormone treatment. The treatment works by giving off radiation that can damage

Who is the study for?

This trial is for men with advanced metastatic castration-resistant prostate cancer (mCRPC), which has spread and doesn't respond to hormone therapy. Participants should be able to undergo various tests, including blood work, heart exams, imaging scans like CT or MRI, and possibly provide tumor samples.

What is being tested?

The study is testing a new treatment called BAY3563254 that targets prostate cancer cells with radiation. It's given as an injection every 6 weeks for up to 4 cycles. The first part of the study determines the safest dose; the second part uses this dose in more people.

What are the potential side effects?

Possible side effects include reactions at the injection site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, kidney issues from radiation exposure and other organ-specific inflammation due to targeted radiotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has worsened despite treatment.

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I am on a consistent dose of blood thinner medication.

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My prostate cancer is advanced and does not have certain aggressive features.

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I have been treated with a drug targeting the androgen axis before.

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I have a PSMA-positive lesion confirmed by a PET/CT scan.

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I have undergone orchiectomy or am on hormone therapy with low testosterone levels.

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I have previously been treated with a taxane.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously received treatment with 225Ac.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 weeks or later (up to 18 months after end of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 weeks or later (up to 18 months after end of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks or later (up to 18 months after end of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation and Dose Expansion: Incidence of TEAEs (including TESAEs)

Dose Escalation and Dose Expansion: ORR by PCWG3 guideline based on Investigator review

Dose Escalation and Dose Expansion: PSA50 response

+2 more

Secondary study objectives

Dose Escalation and Dose Expansion: Duration of PSA50 response

Dose Escalation and Dose Expansion: Duration of response (DOR) by PCWG3 based on Investigator review

Dose Escalation and Dose Expansion: Radiologic progression-free survival (rPFS) by PCWG3 based on Investigator review

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: HPGe or NaI Whole Body Radioactivity Measurement of 225Ac-PSMA-TrilliumExperimental Treatment1 Intervention

HPGe or NaI measurements of whole-body radioactivity of 225Ac and its daughters as a function of time will be conducted on an optional basis during dose escalation and dose expansion at selected sites to evaluate the clearance of total radioactivity from the body over time. Participants in the 111In-PSMA-Trillium and Tris-POC Imaging Substudy will not be eligible for this HPGe or NaI Whole Body Radioactivity Measurement of 225Ac-PSMA-Trillium Substudy.

Group II: Dose expansion group C of BAY3563254Experimental Treatment1 Intervention

Participants with advanced mCRPC treated with 225Ac-PSMA-Trillium, who must have had prior treatment with 177Lu-PSMA more than 6 weeks before the start of study treatment and at least 1 but no more than 2 taxane regimens (or been deemed ineligible for or refused taxane therapy on consultation with their physician).

Group III: Dose expansion group B of BAY3563254Experimental Treatment1 Intervention

Participants with advanced mCRPC treated with 225Ac-PSMA-Trillium, who must not have received taxane-based chemotherapy since becoming castration resistant. Prior radiopharmaceutical treatment is not permitted.

Group IV: Dose expansion group A of BAY3563254Experimental Treatment1 Intervention

Participants with advanced mCRPC treated with 225Ac-PSMA-Trillium, who must have received at least 1 but no more than 2 prior taxane-based chemotherapy regimens. Prior radiopharmaceutical treatment is not permitted.

Group V: Dose escalation of BAY3563254Experimental Treatment1 Intervention

Participants with advanced mCRPC will receive increased 225Ac-PSMA-Trillium doses in a planned stepwise fashion.

Group VI: 225Ac-PSMA-Trillium Imaging and DosimetryExperimental Treatment1 Intervention

The 225Ac-PSMA-Trillium Imaging and Dosimetry Substudy will enroll throughout both dose escalation and dose expansion, starting with the first dose level in dose escalation. The substudy will generally be available at all study sites to participants in the main study.

0 / 9Eligibility criteria met