Active — Not RecruitingPhase 3

177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer

United States439 participantsStarted 2022-02-14

Plain-language summary

A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I\&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Male 18 years or older able to understand and provide signed written informed consent.
✓. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
✓. Progressive disease by one or more of the following criteria:
✓. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of \>2 ng/mL.
✓. Progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria).
✓. Previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide).
✓. Must have received no more than one previous AR-directed therapy.
✓. Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting.

Exclusion criteria

✕. Prior treatment with radioligand therapy including other lutetium-labeled compounds.
✕. Prior treatment with radium-223 (Xofigo) within the past 12 weeks.
✕. Prior chemotherapy treatment for castration-resistant prostate cancer. Prior docetaxel use in the hormone-sensitive setting is permitted, as long as no more than 6 doses were received, the last dose was administered \>1 year prior to consent, and disease progression did not occur during docetaxel treatment.
✕. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
✕. Patients with known HRR gene-mutation (BRCA 1/2 encompassing both germline and somatic) who have not been previously treated with olaparib or rucaparib.
✕. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
✕. Inadequate organ and bone marrow function as evidenced by:
✕. Hemoglobin \< 8 g/dL.

What they're measuring

Radiographic Progression Free Survival

Timeframe: 34 weeks

Trial details

NCT IDNCT05204927

SponsorCurium US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-02

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