This is a single-arm, open-label study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of SRT-017 radioligand therapy in patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). All eligible participants will receive SRT-017 intravenous treatment. The primary objectives are to assess safety and tolerability. Secondary objectives include radiation dosimetry, pharmacokinetics, and preliminary antitumor activity.
Male participants aged 18 years or older.
Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant prostate cancer (mCRPC). mCRPC is defined as disease progression under continuous androgen-deprivation therapy (ADT) or after prior bilateral orchiectomy, with serum testosterone maintained at castrate level (<50 ng/dL or <1.7 nmol/L), meeting at least one of the Prostate Cancer Working Group 3 (PCWG3) progression criteria: PSA progression (PSA ≥1 ng/mL, ≥25 % increase compared with PSA nadir with an absolute rise ≥2 ng/mL confirmed by two consecutive measurements at least 1 week apart); or radiographic progression (≥2 new bone metastatic lesions on bone scan, or soft-tissue disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)).
Disease progression after treatment with at least one novel androgen-axis drug (NAAD), including abiraterone, enzalutamide, apalutamide, or darolutamide.
Prior chemotherapy, or participants who are ineligible for chemotherapy or decline chemotherapy.
Participants unable to tolerate required imaging examinations.
Received systemic anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy; endocrine therapy is exempt), investigational medicinal products, or investigational medical devices within 4 weeks prior to first study drug administration.
Received prior radiopharmaceutical therapy (such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, lutetium-177) within 6 months before first dose; or received external-beam radiation therapy (EBRT) within 2 months before first dose.
Persistent Grade 4 myelosuppression from prior anti-cancer therapy within 2 weeks before screening, or Grade 3 myelosuppression with recovery duration longer than 6 weeks.
Single group
SRT-017
DrugInvestigational PSMA-targeted radiopharmaceutical, administered intravenously for male patients with metastatic castration-resistant prostate cancer (mCRPC). Dosing and administration will follow the study protocol.
Outcome Measure：Percentage of Participants With Confirmed PSA Response (≥50% PSA Decline)
Proportion of participants achieving confirmed ≥50% PSA reduction from baseline according to PCWG3 criteria. Confirmation requires a second PSA measurement at least 4 weeks later sustaining ≥50% decline.
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