A Japanese Phase 2 study of 177Lu-PSMA-617 in participants with PSMA(+) mCRPC

Phase 2

• Conditions: Prostate Cancer

• Registration Number: JPRN-jRCT2041210123
• Lead Sponsor: Kazuyuki Suzuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 28

Inclusion Criteria

ECOG performance status:
1. Post-taxane population only: 0 to 2.
2. Pre-taxane population only: 0 to 1.
- Participants must have a previous histological, pathological, and/or cytological confirmation of prostate cancer.
- Participants must have a positive 68Ga-PSMA-11 PET/CT scan, as determined by the sponsor's central reader, before the enrollment to 177Lu-PSMA-617 treatment period.
- Participants must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
- Post-taxane population only: Participants must have received at least one ARDT (for example enzalutamide, abiraterone, apalutamide, or darolutamide, etc.) in either the hormone-sensitive/castrate-resistant or non-metastatic/metastatic prostate cancer setting.
- Pre-taxane population only: Participants must have received one prior approved ARDT (for example, abiraterone, enzalutamide, darolutamide, or apalutamide, etc.) and have documented progression on therapy and be a candidate for additional treatment with an alternate ARDT as assessed by the treating physician
- Post-taxane population only: Participants must have been previously treated with at least 1, but no more than 2 prior taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a participant has received only 1 taxane regimen, the participant is eligible if :
a. The participant's physician deems him unsuitable to receive a second taxane regimen (e.g., frailty assessed by geriatric or health status evaluation or intolerance, etc.).
- Participants must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
1. Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
2. Soft-tissue progression defined as an increase >=20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions.
3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (PCWG3 criteria, Scher et al 2016).
- Participants must have at least one measurable lesion per PCWG3-modified RECIST v1.1 on CT or MRI.

Exclusion Criteria

- 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 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.
- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitors, or AKT inhibitors or investigational therapy.
- Participants with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity.
- Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.

Study & Design

• Study Type: Interventional
• Study Design: Not specified