← Back to Search

Radioisotope Therapy

111In-PSMA-Trillium and Tris-POC Imaging for 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

PAnTHA Trial 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.Check my eligibility

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.See study design

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.

PAnTHA Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My prostate cancer has worsened despite treatment.

Select...

I am on a consistent dose of blood thinner medication.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I have previously been treated with a taxane.

Select...

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

PAnTHA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

+3 more

Secondary outcome measures

Dose Escalation and Dose Expansion: AUC and AUC(0-tlast) of 225Ac

Dose Escalation and Dose Expansion: AUC and AUC(0-tlast) of PSMA-Trillium-macropa peptide

Dose Escalation and Dose Expansion: Cmax of 225Ac

+6 more

PAnTHA 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.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,240 Previous Clinical Trials

25,332,659 Total Patients Enrolled

39 Trials studying Prostate Cancer

25,919 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration officially approved Dose Expansion Group B for the medication known as BAY3563254?

"Given that this trial is in Phase 1, which implies a limited amount of data supporting both safety and efficacy, our assessment at Power rates the safety of Dose expansion group B for BAY3563254 as a score of 1."

Answered by AI

Is the enrollment process open for this medical study at present?

"According to the current information available on clinicaltrials.gov, this particular clinical trial is not actively seeking participants. The study was initially posted on March 29th, 2024 and was last edited on January 11th, 2024. However, it's worth noting that there are currently 1233 other ongoing studies that are enrolling participants at the moment."

Answered by AI

Are there a significant number of medical facilities conducting this study within the borders of the United States?

"Among the participating centers for this trial, notable sites include Royal Marsden NHS Trust in Sutton (Surrey), Institut Jules Bordet / Nuclear Medicine in Anderlecht, and AZ Groeninge Campus Kennedylaan - Urology in Kortrijk. There are also five additional locations involved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)

2024. "First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06217822.