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CancerPhase 2LUBASKETNCT05867615

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

A Phase 2 study testing [177Lu]Lu-PSMA I&T in people with Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
[177Lu]Lu-PSMA I&T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
2 sitesItaly
Study dates
25 May 2023to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 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;
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  • 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)
  • 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. If female of childbearing potential highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials", (See Appendix F) are mandatory. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months;
  • Participant is willing and able to give informed consent for participation in the study.
  • The participant may not enter the study if ANY of the following apply:
  • 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 ≤ 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.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • UO Medicina Nucleare, AUSL della Romagna

    Cesena, 47521

  • UO Medicina Nucleare, IRCCS IRST

    Meldola, Forlì, 47014

Other trials in Italy

About this study

Official title: Radiometabolic Therapy (RMT) With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours: a Basket Trial

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)

Read the detailed description

Since PSMA radioligand therapy (PSMA-RLT) demonstrated remarkable therapeutic efficacy in prostate cancer patients, the question arises whether PSMA-RLT could also achieve beneficial effects in other cancers expressing PSMA on the tumors cells themselves, or in the tumor-associated neovasculature. Expression of PSMA was early-on also identified in kidney, salivary glands, the duodenum and the central and peripheral nervous system. Subsequently, a wide variety of immunohistochemistry (IHC) studies showed PSMA to be upregulated on the endothelial cells of the neovasculature of a wide variety of other solid tumors where it may facilitate endothelial cell sprouting and invasion through its regulation of lytic proteases that have the ability to cleave the extracellular matrix. Similar to the introduction of PSMA-targeting theranostics in prostate carcinoma, overexpression of PSMA on newly formed tumor vessels may serve as a target for imaging and subsequent treatment of cancer through the use of agents that are capable of blocking PSMA in its function or through PSMA-mediated delivery of chemotherapeutics or radiation agents. Preclinical data suggests that PSMA might be involved in cancer-related angiogenesis by degrading the extracellular matrix and participating in integrin signal transduction.

Conditions
Cancer
Being tested
[177Lu]Lu-PSMA I&T
Keywords
basket study, PSMA PET/CT positive
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [177Lu]Lu-PSMA I&TDrug

    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.

Study groups in NCT05867615
Study groupRoleWhat they receive
[177Lu]Lu-PSMA I&TExperimental[177Lu]Lu-PSMA I\&T, intravenous, dosage of 5.5 - 7.4 GBq every 8 weeks
Receives: Drug: [177Lu]Lu-PSMA I&T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 40 months

  2. 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

    Measured: 40 months

Secondary outcomes (4)

  1. progression-free survival (PFS)

    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 Prostate Cancer Clinical Trials Working Group (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.

    Measured: 68 months

  2. overall survival (OS)

    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.

    Measured: 68 months

  3. late toxicity

    The late toxicity is the toxicity that occurred after 30 days from the last treatment administration up to 6 months.

    Measured: 68 months

  4. PET/CT response

    PET/CT response is based on Standardized Uptake Value (SUV). PET/CT response will be evaluated with descriptive statistics.

    Measured: 68 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start25 May 2023
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05867615
Sponsor's protocol ID
IRST100.58
Acronym
LUBASKET
Status last verified
Dec 2025
First submitted
24 Mar 2023
Last updated
3 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [177Lu]Lu-PSMA I&T in people with Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicity rate (time frame: 40 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05867615.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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