Suspended

177Lu-PSMA-617 for Metastatic Castration-resistant Prostate Cancer in Japan

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Study Aim

This study aims to evaluate the safety and response rate of 177Lu-PSMA-617 treatment in Japanese men with metastatic prostate cancer that is resistant to castration.

What is being tested

177Lu-PSMA-617

+ 68Ga-PSMA-11

+ Best supportive/best standard of care

RadiationOther
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

From 20 to 100 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2022
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 25, 2022

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a treatment called 177Lu-PSMA-617 for men in Japan who have a specific type of advanced prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). This cancer is resistant to standard hormone treatments and has spread to other parts of the body. The study targets two groups: those who have already tried taxane chemotherapy and those who have not. The aim is to see how well the treatment works, how safe it is, and how it's processed in the body, which could lead to better treatment options for these patients. Participants in the trial will receive the 177Lu-PSMA-617 treatment, which is given once every six weeks. The study will assess how well the treatment is tolerated, any side effects, and how effective it is in shrinking the cancer. This involves checking for dose-limiting toxicities, which are side effects serious enough to prevent further administration of the treatment. The trial is divided into several parts, focusing on different participant groups and treatment stages. It also includes a long-term follow-up period to monitor ongoing health effects after the treatment ends. This comprehensive approach helps ensure that the treatment is both safe and effective before it becomes widely available.

Official TitleA Prospective, Open Label, Multicenter, Single Arm, Phase 2 Study of 177Lu-PSMA-617 in the Treatment of Participants With Progressive PSMA- Positive Metastatic Castration-resistant Prostate Cancer (mCRPC) in Japan
NCT05114746
Principal SponsorNovartis Pharmaceuticals
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

87 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

7 exclusion criteria prevent from participating
Previous treatment with any of the following within 6 months of the enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted therapy is not allowed
Post-taxane population: Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies], ARDT is not included) within 28 days prior to day of the enrollment
Pre-taxane population: Prior treatment with PARP inhibitor, cytotoxic chemotherapy for castration resistant or castrate sensitive prostate cancer (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy [including monoclonal antibodies]) [Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy]
Known hypersensitivity to the components of 177Lu-PSMA-617, 68Ga-PSMA-11 or excipients or to drugs of similar classes
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
PSMA positivity will be confirmed by PET/CT scan after administration of 68Ga-PSMA-11. All eligible participants will receive recommended dose of 177Lu-PSMA-617 via intravenous injection every 6 weeks (+/- 1 week) for a maximum of 6 cycles.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

Novartis Investigative Site

Kashiwa, JapanOpen Novartis Investigative Site in Google Maps
Suspended

Novartis Investigative Site

Sapporo, Japan
Suspended

Novartis Investigative Site

Kobe, Japan
Suspended

Novartis Investigative Site

Kanazawa, Japan
Suspended8 Study Centers