Clinical trial · Interventional
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC
A Prospective, Open-label, Multi-center, Single-arm, Phase II Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
The purpose of this study was to assess the efficacy, safety, tolerability, Pharmacokinetic(s) (PK) and dosimetry of \[177Lu\]Lu-PSMA-617 when administered in addition to Best Supportive/Best Standard of Care (BSC/BSoC) in Chinese participants with progressive PSMA-positive mCRPC who received at least 1 novel androgen receptor pathway inhibitor (ARPI) and were previously treated with 1 to 2 taxane regimens. Furthermore, the safety, PK, and dosimetry of \[68Ga\]Ga-PSMA-11 were assessed. Data from this study will be used to bridge global pivotal phase III study (VISION, AAA617A12301) and to support China registration of \[177Lu\]Lu-PSMA-617 as a novel anticancer modality, namely radioligand therapy, in mCRPC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [177Lu]Lu-PSMA-617 | Drug | — | UNRESOLVED |
| 68Ga-PSMA-11 | Drug | — | UNRESOLVED |
| Best supportive/best standard of care (BS/BSOC) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [177Lu]Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)
- description
- Patients received the investigational product 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) could be used.
- interventionNames
- Drug: [177Lu]Lu-PSMA-617
- Other: Best supportive/best standard of care (BS/BSOC)
- Drug: 68Ga-PSMA-11
Primary outcomes (1)
- measure
- Main part: Confirmed Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)
- timeFrame
- From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, approx. 1 year
- description
- Confirmed Overall Response Rate (ORR) is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR is based on PCWG3-modified RECIST v1.1 response for patients with measurable disease at baseline.
Secondary outcomes (20)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent must be obtained before any assessment is performed. * Participants must be Chinese male adults \>= 18 years of age. * Participants must have histological, pathological, and/or cytological confirmation of prostate cancer. * Participants must be \[68Ga\]Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader according to the VISION read rules. * Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7 nmol/L). * Participants must have received at least one ARPI (such as enzalutamide and/orabiraterone). * Participants must have been previously treated with at least 1, but no more than 2 previous 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: the participants' physician deems him unsuitable to receive a second taxane regimen (e.g., frailty assessed by geriatric or health status evaluation or intolerance, etc.) * Documented progressive mCRPC, based on at least 1 of the following criteria: * Serum/plasma PSA progression defined as 2 consecutive increases in PSA measured at least 1 week apart, the minimal start value is 2.0 ng/ml * Soft-tissue progression defined based on PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016) * Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et al 2016) * Participants must have \>= 1 metastatic lesion that is present on baseline CT, MRI or bone scan imaging obtained =\< 21 days prior to enrollment via central reading. * In main part: participant must have at least one measurable lesion by PCWG3-modified RECIST v1.1 via central reading * Participants must have adequate organ function: * Bone marrow reserve: * White blood cell (WBC) count \>= 2.5 × 109/L OR absolute neutrophil count (ANC) \>= 1.5 × 109/L * Platelets \>=100 × 109/L * Hemoglobin \>= 9 g/dL * Hepatic: * Total bilirubin =\< 1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome =\< 3 × ULN is permitted * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\< 3.0 × ULN OR =\< 5.0 × ULN for participants with liver metastases * Renal: * eGFR \>= 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation * Albumin \>3.0 g/dL. Exclusion Criteria: * Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation. * Previous PSMA-targeted radioligand therapy. * Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\], APRI is not included) within 28 days prior to day of enrollment. * Any investigational agents (e.g. poly adenosine diphosphate-ribosyl polymerase inhibitors \[PARPi\]) within 28 days prior to day of enrollment. * History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes. * Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. * Transfusion for the sole purpose of making a subject eligible for study inclusion. * Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. * Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids. * Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. * Symptomatic spinal cord compression, or clinical or radiologic findings indicative of impending cord compression.
References
Publications (1)
- DERIVEDShi H, Guo J, Fan W, Li Y, Huang R, Dong Q, Yang Z, Yang Y, Wang X, Gu D, Huo L, Ji Z, Wang F, Xu D, Jiang Z, Li H, Li J, Li R, Qi L, Wang J, Ye D. A phase II study evaluating pharmacokinetics and dosimetry of 177Lu-PSMA-617 radioligand therapy in Chinese participants with progressive metastatic castration-resistant prostate cancer. EJNMMI Res. 2026 Mar 1;16(1):55. doi: 10.1186/s13550-026-01401-3. PMID 41764712