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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

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 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

Trial Design

7Treatment 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.
Group VII: 111In-PSMA-Trillium and Tris-POC ImagingExperimental Treatment3 Interventions
Participants who sign informed consents for both the main study and the optional 111In-PSMA-Trillium and Tris-POC Imaging Substudy. 111In-PSMA-Trillium and Tris-POC Imaging Substudy participants are not eligible for the 225Ac-PSMA-Trillium Imaging and Dosimetry Substudy or for the dense-PK sub-cohort in dose expansion. Each substudy participant will enter the 111In-PSMA-Trillium and Tris-POC Imaging Substudy period after completing a shortened screening period and before starting study treatment with 225Ac-PSMA-Trillium.

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,260 Previous Clinical Trials
25,309,327 Total Patients Enrolled
42 Trials studying Prostate Cancer
26,048 Patients Enrolled for Prostate Cancer
~79 spots leftby Jun 2027
Unbiased ResultsWe believe in providing patients with all the options.
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