Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation

Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation - LU-PSMA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002732-32-IT

Enrollment

210

Registered

2019-09-06

Start date

2017-02-15

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced castration resistant prostate cancer (CRPC) MedDRA version: 20.0 Level: LLT Classification code 10007453 Term: Carcinoma of the prostate metastatic System Organ Class: 100000004864

Interventions

Product Name: 177LU-PSMA617_IRSTIRCCS Product Code: 177LU-PSMA617_IRSTIRCCS Pharmaceutical Form: Solution for infusion Current Sponsor code: 177LU-PSMA617_IRSTIRCCS Other descriptive name: 177LU-PSMA6

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Patients must have histologically or cytologically confirmed prostate cancer 2. Male, aged = 18 years. 3. Metastatic castration resistant prostate cancer 4. 68Ga-PSMA PET/CT positive in known site of disease, documented by CT or MRI or bone scan or 18Coline-PET 5. Patients with clinical progression from previous treatment Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: 1. Patients treated with chemotherapy and 223Ra radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy. 2. ECOG performance status >2 3. Assessed bone marrow invasion > 50%

Design outcomes

Primary

Measure	Time frame
Main Objective: is to evaluate the Disease Control Rate (DCR) and the safety ;Secondary Objective: late toxicity, Progression Free Survival (PFS), Overal Survival (OS), biochemical response and dosimetry;Primary end point(s): Disease Control Rate (DCR) and safety ;Timepoint(s) of evaluation of this end point: 46 months	—

Secondary

Measure	Time frame
Secondary end point(s): dosimetry;Timepoint(s) of evaluation of this end point: 46 months	—

Countries

Italy

Contacts

Public ContactCentro di Coordinamento Studi IRST

IRST IRCCS

cc.ubsc@irst.emr.it+390544285813

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026