Study of JSB462 and lutetium (177Lu) vipivotide tetraxetan combination for adult men with PSMA-positive metastatic castration resistant prostate cancer

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What is this study about?

This study focuses on patients with metastatic castration resistant prostate cancer (mCRPC) that is PSMA-positive. The research evaluates a combination treatment using two medications: luxdegalutamide (also known as JSB462) and lutetium vipivotide tetraxetan. Luxdegalutamide is taken as a tablet by mouth, while lutetium vipivotide tetraxetan is given through an intravenous injection.

The purpose of this research is to determine the most effective dose of luxdegalutamide when used together with lutetium vipivotide tetraxetan, and to compare this combination treatment to using lutetium vipivotide tetraxetan alone. Before starting the treatment, patients will undergo imaging tests including a special type of scan called gallium gozetotide PET/CT to confirm if they are suitable for the study.

During the study, patients will be randomly assigned to receive either the combination of both medications or lutetium vipivotide tetraxetan by itself. The treatment period may continue for up to 36 months. Throughout the study, doctors will monitor how well the treatment is working and check for any side effects. They will also perform regular blood tests to measure PSA (prostate-specific antigen) levels, which help track the progress of the treatment.

1 Initial screening

A PET/CT scan will be performed to confirm if your cancer is suitable for the treatment (PSMA-positive).

Your medical history will be reviewed to confirm eligibility, including previous treatments and current health status.

Basic health checks will be performed, including assessment of your ability to perform daily activities (ECOG Performance Status).

2 Treatment assignment

You will be randomly assigned to receive either:

– Luxdegalutamide tablets (100mg or 300mg daily) plus intravenous lutetium treatment

– Intravenous lutetium treatment alone

3 Treatment administration

If assigned to the combination group, you will take luxdegalutamide tablets orally once daily

All participants will receive lutetium treatment through intravenous infusion

Regular blood tests will be performed to monitor PSA levels (a protein that may indicate prostate cancer activity)

Imaging scans will be conducted to monitor your response to treatment

4 Monitoring and follow-up

Regular health assessments will track any side effects

Blood samples will be taken to measure drug levels in your body

Imaging scans will be performed to check tumor response

You will be asked to report any symptoms or changes in your condition

The study will continue until December 2028

Who Can Join the Study?

Must be an adult male with confirmed prostate cancer of type adenocarcinoma (a type of cancer that starts in gland cells)
Must have a physical fitness score (ECOG Performance Status) of 2 or less, meaning you can perform most daily activities with minimal assistance
Must have at least 1 cancer spread (metastatic lesion) in bones or organs, confirmed by CT scan, MRI, or bone scan within 28 days before starting treatment
Must have a positive gallium PET/CT scan (a special type of imaging test that shows where cancer cells are in the body)
Must have previously received at least one newer generation hormone therapy (ARPI) for advanced prostate cancer
Can have had up to 2 previous chemotherapy treatments with taxane medications (drugs used to treat cancer)
If eligible for PARPi (targeted therapy drugs) or immune checkpoint inhibitors (drugs that help immune system fight cancer), must have already received these treatments

Who Cannot Join the Study?

History of other cancers within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ
Presence of active brain metastases (spread of cancer to the brain)
Known hypersensitivity (allergic reaction) to the study medications or their components
Severe heart conditions, including:
- Uncontrolled high blood pressure
- Unstable heart disease
- Heart attack within the past 6 months
Severe liver problems or abnormal liver function tests
Significant kidney disease requiring dialysis
Active, uncontrolled infections
Participation in another clinical trial within 30 days before starting this study
Any condition that, in the opinion of the study doctor, would interfere with safe participation in the study
Unable to swallow oral medications
Major surgery within 4 weeks before starting the study
Mental conditions that could affect the ability to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Frisius	Heerenveen	The Netherlands
Rostock University Medical Center	Rostock	Germany

Other Sites

Site Name	City	Country
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
University Hospital Olomouc	Olomouc	Czechia
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Spaarne Gasthuis	Hoofddorp	The Netherlands
Cwziei Htlwtctaruy Rqwkytgq Ussnsjjpecwxg Dm Tqdlm	Tours	France
Uglaxwtxsnpmuorbiklkv Eerqb Afn	Essen	Germany
Iynpqe Iausugxi Fqgcepqberxhb Ousrazigjut	Rome	Italy
Obabqgrggticfg Lcjn Gkag	Linz	Austria
Fgyeqogu ntaktqjpq Mtlze a Hmuyfqr	Prague	Czechia
Hxqnybyb Vtlc dxmspdga	Barcelona	Spain
Iunkzafs Ptydyljgiubmdjc Cvnehn Cdmjyi	Marseille	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	15.10.2025
Czechia	Not recruiting	15.10.2025
France	Not recruiting	15.10.2025
Germany	Not recruiting	15.10.2025
Italy	Not recruiting	15.10.2025
Spain	Not recruiting	15.10.2025
The Netherlands	Not recruiting	15.10.2025

Trial locations

Investigated drugs:

JSB462 is an investigational medication being studied in combination with another treatment for prostate cancer. It is being tested at different doses to determine which dose works best for future studies.

Lutetium (177Lu) vipivotide tetraxetan is a radioactive medication used to treat certain types of prostate cancer. It works by targeting specific proteins found on prostate cancer cells (called PSMA) and delivering radiation directly to these cancer cells. The medication is given through an intravenous infusion.

AAA617 appears to be another code name for lutetium (177Lu) vipivotide tetraxetan used in this clinical trial. It is the same radioactive treatment described above that targets prostate cancer cells.

Metastatic castration resistant prostate cancer (mCRPC) – A form of advanced prostate cancer that continues to progress despite medical or surgical treatments that lower testosterone. In this condition, cancer cells have spread beyond the prostate to other parts of the body (metastasized), commonly to bones, lymph nodes, or other organs. The cancer continues to grow even when testosterone levels in the body are reduced to very low levels. This stage of prostate cancer typically develops gradually, with cancer cells becoming resistant to hormone therapy over time. The disease is characterized by rising prostate-specific antigen (PSA) levels and/or visible growth of tumors on imaging scans.

Trial ID:

2024-520155-24-00

Protocol code:

CJSB462B12201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of JSB462 and lutetium (177Lu) vipivotide tetraxetan combination for adult men with PSMA-positive metastatic castration resistant prostate cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?