177LU-PSMA-I&T for PSMA-positive advanced/metastatic solid tumours | Prostate cancer

Inclusion criteria

• {"criterion_text":"- 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;\n- patients must have measurable disease; patients with prostate cancer who have only bone lesions can be enrolled;\n- relapse or progression of disease on CT/MRI scan and/or WBD-MRI;\n- 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 g >=1 ng/ml) according to PCWG3;\n- patients will be admitted to therapeutic phase only if the diagnostic PET/CT PSMA SUV max is >= g 3;\n- no therapeutic alternatives\n- male or Female, aged >= 18 years\n- life expectancy of greater than 12 weeks\n- ECOG performance status <= 2\n- patients must have normal organ and marrow function as defined below: leukocytes >= 3,000/µL; absolute neutrophil count >= 1,500/µL; hemoglobin >= 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); AST(SGOT)/ALT(SGPT) <= 2.5 X institutional upper normal limit (< 5 X UNL in presence of liver metastases); creatinine <= 2 mg/dL\n- A female participant is eligible to participate if she is not pregnant and not breastfeeding;\n- Participant is willing and able to give informed consent for participation in the study."}

Exclusion criteria

• {"criterion_text":"- patients who have completed chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) and hormonotherapy within 2 weeks (excluding mCRPC patients), prior to treatment start. A window of 3 days is permitted;\n- all acute toxic effects of any prior therapy (including surgery, radiation therapy, and chemotherapy) must have resolved to a grade f 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE);\n- participation in another clinical trial with any investigational agents within 30 days prior to study treatment start. A window of 3 days is permitted;\n- history of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-PSMAs or other agents used in the study\n- medical or psychological conditions that would not allow the participant to understand, or sign the informed consent;\n- uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements."}

Primary endpoints

• {"endpoint_text":"- 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 patients with prostate cancer (according to PCWG3 criteria), at the 1st planned evaluation. Safety, evaluated according to version 5.0 CTC-AE. Safety is defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle.","definition_or_measurement_approach":"DCR defined as percentage of patients achieving complete response, partial response, stable disease (RECIST 1.1) or no progression for prostate cancer patients (PCWG3) at the 1st planned evaluation. Safety evaluated according to CTCAE version 5.0 and defined as percentage of patients experiencing acute toxicity from first treatment until 30 days after last treatment cycle."}

Secondary endpoints

• {"endpoint_text":"- PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression (according to RECIST 1.1 or PCWG3 criteria for prostate cancer patients) or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.","definition_or_measurement_approach":"PFS measured as time from treatment start to documented disease progression (RECIST 1.1 or PCWG3 for prostate cancer) or death; censoring at last tumor evaluation if no progression."}
• {"endpoint_text":"- Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.","definition_or_measurement_approach":"Overall survival measured as time from therapy start to death from any cause or censored at date of last contact."}
• {"endpoint_text":"- The late toxicity is the toxicity that occurred after 30 days from the last treatment administration up to 6 months.","definition_or_measurement_approach":"Late toxicity defined as toxicity occurring >30 days after last treatment administration up to 6 months."}
• {"endpoint_text":"- PET/CT response is based on SUV. The dosimetry objective is evaluated through pharmacokinetic measures, biodistribution activity and absorbed dose to salivary gland (critical organ), kidneys, bone marrow and tumour.","definition_or_measurement_approach":"PET/CT response assessed by SUV; dosimetry evaluated via pharmacokinetic measures, biodistribution activity and absorbed dose to specified organs (salivary gland, kidneys, bone marrow) and tumour."}

Italy

Earliest CTIS Part Ii Submission Date

04-12-2024

Latest Decision Or Authorization Date

15-01-2025

Processing Time Days

42

Number Of Sites

2

Number Of Participants

83

Primary sponsor

Full Name

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy