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Radiometabolic Therapy (RMT) with 177Lu PSMA in PSMA PET/CT positive advanced/metastatic tumours: a basket trial (LUBASKET)
EU CTIS ID: 2024-519346-75-00
What this study is testing
The main objective of this phase II study is to evaluate the disease control rate (DCR) and safety as co-primary objective in different histologies.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 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
- A female participant is eligible to participate if she is not pregnant and not breastfeeding;
- Participant is willing and able to give informed consent for participation in the study.
- patients must have measurable disease; patients with prostate cancer who have only bone lesions can be enrolled;
- relapse or progression of disease on CT/MRI scan and/or WBD-MRI;
You likely can't join if
- 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;
- 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);
- participation in another clinical trial with any investigational agents within 30 days prior to study treatment start. A window of 3 days is permitted;
- history of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-PSMAs or other agents used in the study
- medical or psychological conditions that would not allow the participant to understand, or sign the informed consent;
- 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.
See the full eligibility criteria
Who can join
- 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 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
- A female participant is eligible to participate if she is not pregnant and not breastfeeding;
- Participant is willing and able to give informed consent for participation in the study.
- patients must have measurable disease; patients with prostate cancer who have only bone lesions can be enrolled;
- 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 g >=1 ng/ml) according to PCWG3;
- patients will be admitted to therapeutic phase only if the diagnostic PET/CT PSMA SUV max is >= g 3;
- no therapeutic alternatives
- male or Female, aged >= 18 years
- life expectancy of greater than 12 weeks
- ECOG performance status <= 2
What rules you out
- 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;
- 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);
- participation in another clinical trial with any investigational agents within 30 days prior to study treatment start. A window of 3 days is permitted;
- history of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-PSMAs or other agents used in the study
- medical or psychological conditions that would not allow the participant to understand, or sign the informed consent;
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.