Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:

NCT05867615 | Active Not Recruiting Phase 2

• 1 other identifier: IRST100.58
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

Phase 2 study, single arm trial enrolling patients with a Gallium-68/Fluorine-18 prostate-specific membrane antigen (PSMA) positive positron emission tomography/Computed Tomography (PET/CT) in order to be treated with Lutetium-177 (177Lu) PSMA. Patients without risk factors for toxicity will receive 7.4 GBq of 177Lu-PSMA while patients with at least 1 risk factor for toxicity will receive 5.5 GBq of 177Lu-PSMA. Patients will receive 4 cycles every 8 weeks (+- 2 weeks)

Conditions

Cancer

Keywords

basket study; PSMA PET/CT positive

Outcome Measures

Primary Outcomes (2)

• Acute toxicity rate

  safety is evaluated according to version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE). Safety is defined as the percentage of patients who experience acute toxicity grade3/grade4 from the 1st treatment until 30 days after the last treatment cycle.

  40 months

• disease control rate (DCR)

  is DCR, defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1) or no progression of disease for prostate cancer (according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria) at the 1st planned evaluation

  40 months

Secondary Outcomes (4)

• progression-free survival (PFS)

  68 months

• overall survival (OS)

  68 months

• late toxicity

  68 months

• PET/CT response

  68 months

Study Arms (1)

[177Lu]Lu-PSMA I&T

EXPERIMENTAL

\[177Lu\]Lu-PSMA I\&T, intravenous, dosage of 5.5 - 7.4 GBq every 8 weeks

Drug: [177Lu]Lu-PSMA I&T

Interventions

[177Lu]Lu-PSMA I&T DRUG

177Lu activity to be administered to single patient (range 5.5-7.4 GBq), every 8 weeks (±2 weeks) will be measured in a dose calibrator, properly calibrated for the radionuclide. The radiopharmaceutical will be slowly infused intravenously over 15-30' in a dedicated room using a dedicated pump system.

[177Lu]Lu-PSMA I&T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed advanced/metastatic solid tumors; any other tumor types documented as PSMA-positive that may benefit from receptor radionuclide therapy and for which there aren't any other effective treatments. For cerebral PSMA-positive tumors, if biopsy is no feasible for technical reasons or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 18F- and/or 68Ga PET-CT PSMA positivity;
• Patients must have measurable disease; patients with prostate cancer who have only bone lesions can be enrolled. See section 9.2 and Appendix D for the evaluation of measurable disease;
• Relapse or progression of disease on CT/MRI scan and/or WBD-MRI;
• For patients with prostate cancer: documented radiological progression (in soft tissue and / or bone) and/or biochemical progression (sequence of PSA rising values from a minimal starting value ≥ 1 ng/ml) according to PCWG3;
• Patients will be admitted to therapeutic phase only if the diagnostic PET/CT PSMA SUV max is ≥ 3;
• No therapeutic alternatives;
• Male or Female, aged ≥ 18 years;
• Life expectancy of greater than 12 weeks;
• ECOG performance status ≤ 2 (see Appendix A);
• Patients must have normal organ and marrow function as defined below:
• leukocytes ≥ 3,000/μL
• absolute neutrophil count ≥ 1,500/μL
• haemoglobin ≥ 9 g/dL
• platelets ≥100,000/μL
• total bilirubin ≤ 1.5 X institutional upper normal limit (this will not apply to patients with confirmed Gilbert's syndrome)

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (2)

UO Medicina Nucleare, IRCCS IRST

Meldola, Forlì, 47014, Italy

Location

UO Medicina Nucleare, AUSL della Romagna

Cesena, 47521, Italy

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Maddalena Sansovini, MD

  IRCCS IRST

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 22, 2023
• Study Start: May 25, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)