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Prostate CancerPhase 2LUSTNCT05893381

Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)

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

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Multicenter, open-label, parallel-group, phase II randomized study in patients with oligometastatic prostate cancer with 1-3 asymptomatic metastases of the soft tissue or bone. Eligible patients will be randomized at 1:1 ratio to Stereotactic Radiotherapy followed by Lu-PSMA (arm A) or Stereotactic Radiotherapy (arm B) Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
[177Lu]Lu-PSMA I&T and Stereotactic Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesItaly
Study dates
27 Jun 2023to Apr 2032
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with prostate cancer must have 1-3 asymptomatic metastatic lesions that are ≤ 5.0 cm or < 250 cm3 documented at CT/MRI or WBD-MRI.
  • PSMA-PET/CT positive scan matching with lesions documented on baseline CT/MRI or WBD-MRI.
  • Patients must have had their primary tumor treated with surgery and/or radiation and previous salvage radiation to the prostate bed or pelvis is allowed.
  • Patients will be admitted to the therapeutic phase only if diagnostic PET/CT PSMA SUV max is ≥ 3.
  • Histologic confirmation of malignancy (primary or metastatic tumor).
  • Prostate specific antigen (PSA) ≥ 0.2 ng/mL but ≤ 50 ng/mL and Testosterone ≥ 125 ng/dL.
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  • PSA doubling time (PSADT) < 15 months. PSADT will be calculated using as many PSA values that are available from time of relapse (PSA > 0.2 ng/dL).
  • Patients unfit or refusing ADT.
  • Patients may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patients may have had ADT associated with salvage radiation therapy.
  • Patients must be ≥ 18 years of age.
  • Patient understands the purpose of the study and the procedures required for it; the patient is willing to participate in the study and to sign a written informed consent document.
  • Patients must have an Eastern Cooperative Oncology Group performance status ≤ 2.
  • Patients should have a life expectancy of at least 6 months.
  • Patients must have normal organ and marrow function as defined as:
  • Leukocytes >2,000/μL;
  • Absolute neutrophil count >1,000/μL;
  • Platelets >75,000/μL;
  • total bilirubin within normal institutional limits (this will not apply to patients with confirmed Gilbert's syndrome);
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal;
  • Creatinine within normal institutional limits.
  • If the participant engages in sexual activity with a woman of childbearing potential, a condom must be used together with another highly effective method of contraception during the Treatment Period and for 6 months after the last dose of study intervention. The participant must agree not to donate sperm for the purpose of reproduction during the Treatment Phase and for a minimum of 6 months after receiving the last dose of study intervention.
  • Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Patients and 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, see Appendix F) 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.
  • 16. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Patients and 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.

Who cannot join

  • The participant may not enter the study if ANY of the following apply:
  • No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred more than 6 months prior to enrollment.
  • PSMA -PET/CT scan more than 3 months.
  • Spinal cord compression or impending spinal cord compression.
  • Suspected pulmonary and/or liver metastases.
  • Bone metastasis in a femoral bone.
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  • Previous radiation therapy on the metastatic site.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. A window of 3 days is permitted.
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening. A window of 3 days is permitted.
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177-Lu-PSMA- I \& T or other agents used in the study.
  • 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.
  • Unable to lie flat during or tolerable SABR.
  • Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma);
  • Known HIV-positivity, whether or not symptomatic.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Oriana Nanni contact

+390543739100

cc.ubsc@irst.emr.it

Bernadette Vertogen contact

+390544286058

cc.ubsc@irst.emr.it

Italy2 sites, 2 recruiting

  • UO Medicina Nucleare, AUSL della Romagna

    Cesena, FC, 47521

    Michela Casi, michela.casi@auslromagna.it

    Recruiting

  • UO Medicina Nucleare, IRCCS IRST

    Meldola, FC, 47014

    Emilio Francesco Giunta, +39 0543739100, emilio.giunta@irst.emr.it

    Recruiting

Other trials in Italy

About this study

Official title: A Phase II Randomized Trial of Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Oligometastatic Prostate Cancer (LUST)

Multicenter, open-label, parallel-group, phase II randomized study in patients with oligometastatic prostate cancer with 1-3 asymptomatic metastases of the soft tissue or bone. Eligible patients will be randomized at 1:1 ratio to Stereotactic Radiotherapy followed by Lu-PSMA (arm A) or Stereotactic Radiotherapy (arm B)

Read the detailed description

Biochemical recurrence (BCR), i.e. prostate-specific antigen (PSA) only recurrence occurs in nearly one-third of patients, after primary definitive therapy for prostate cancer.

PSMA (prostate-specific membrane antigen) is an attractive target for diagnosis and therapy of metastasized prostate cancer (PCa) as its expression levels are directly correlated with androgen independence, metastases and progression.

Positron Emission Tomography/Computed Tomography (PET-CT) using PSMA is able to detect > 50% of relapses with PSA between 0.50 and 1 ng/mL and >75% with PSA between 1 and 2.

Oligometastatic prostate cancer include 1-3 asymptomatic metastatic lesion(s) of the soft tissue or bone. The treatment of oligometastatic disease depends on multiple factors including the site, the size, number and location of metastases, and the effectiveness of treatments.

Recent advances in radiation therapy allow to image and treat precisely target lesions within any anatomic region of the body. Stereotactic radiation therapy permit highly conformal and precisely targeted radiation administered in a dose intensive strategy. Local control in excess of 75% has been reported for metastatic prostate cancer with very low toxicity.

Lutetium 177-PSMA (177Lu-PSMA) is the most extensively investigated PSMA radioligand for radionuclide therapy in castration resistant prostate cancer (CRPC). Several retrospective studies and three phase II prospective studies demonstrated safety and impressive efficacy of 177Lu-PSMA in metastatic CRPC (mCRPC).The purpose of this study is to evaluate in a randomized phase II study the impact of Lu-PSMA added to stereotactic radiotherapy vs radiotherapy alone in PSMA detected- metastatic lesions of hormone-sensible prostate cancer.

Conditions
Prostate Cancer
Being tested
[177Lu]Lu-PSMA I&T, Stereotactic Radiotherapy
Keywords
PSMA PET/CT positive
Medical subject headings
Prostatic 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

    Also called 177Lu-PSMA

    The radiopharmaceutical 177Lu-PSMA-I\&T will be administered, by slow intravenous injection, in 2 cycles of treatment at 6-8 weekly intervals at a dosage of 7.4 GBq.

  • Stereotactic RadiotherapyRadiation

    Also called Ablative stereotactic radiation

    Ablative stereotactic radiation on the metastatic sites. Delivered in a 1 to 5 fractions regimen, depending on the target size and the surrounding normal tissue constraints,

Study groups in NCT05893381
Study groupRoleWhat they receive
Stereotactic Radiotherapy followed by Lu-PSMA (arm A)ExperimentalAblative stereotactic radiation on the metastatic sites. Delivered in a 1 to 5 fractions regimen. 177Lu-PSMA-I\&T in 2 cycles of treatment at 6-8 weekly intervals at a dosage of 7.4 Gigabequerel (GBq)
Receives: Drug: [177Lu]Lu-PSMA I&T; Radiation: Stereotactic Radiotherapy
Stereotactic Radiotherapy (arm B)Active comparatorAblative stereotactic radiation on the metastatic sites. Delivered in a 1 to 5 fractions regimen.
Receives: Radiation: Stereotactic Radiotherapy

What is being measured

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

  1. 12-month PSA (Prostate-Specific Antigen)-progression-free survival (PSA-PFS)

    To determine the proportion of men with oligometastatic hormone sensitive prostate cancer who have PSA progressed after 12 months from randomization to Stereotactic Radiotherapy and Lu-PSMA versus Radiotherapy alone.

    Measured: 12-months

Secondary outcomes (5)

  1. 12-month radiographic Progression-free survival (rPFS), Androgen Deprivation Therapy-Free survival (ADT-FS) and Total progression-free survival (PSA-PFS+rPFS)

    To assess radiographic progression free survival (PFS) after 12 months, ADT free survival (ADT-FS) and Total progression-free survival (PSA-PFS+rPFS) of Lu-PSMA + Stereotactic Radiotherapy vs Stereotactic Radiotherapy defined as the time interval between the day of randomization and the day of disease progression.

    Measured: 12-months

  2. Incidence of Treatment-Emergent Adverse Events [Toxicity]

    To describe the toxicity of Lu-PSMA + Stereotactic Radiotherapy vs Stereotactic Radiotherapy for the population enrolled using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: 60 months

  3. Overall survival (OS)

    To assess overall survival (OS) defined as the time interval between the day of randomization and death or last contact.

    Measured: 60 months

  4. Proportion of subjects with undetectable PSA (<0.2 ng/mL)

    To assess proportion of subjects with undetectable PSA (<0.2 ng/mL) defined as a PSA level ≤0.20 ng/mL as measured during routine follow-up

    Measured: 60 months

  5. Quality of life questionnaire (QLQ)

    To assess quality of life in the Lu-PSMA+ Stereotactic Radiotherapy arm vs Stereotactic Radiotherapy only arm using the Functional Assessment of Cancer Therapy - Prostate (FACT-P version 4) questionnaire. The scale ranging from 0-4, where 0 is labeled 'Not at all', and 4 is labeled 'Very Much'.

    Measured: 60 months

Timeline

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

  1. First posted7 Jun 2023
  2. Study start27 Jun 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionApr 2032 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05893381
Sponsor's protocol ID
IRST185.09
Acronym
LUST
Status last verified
Dec 2024
First submitted
30 May 2023
Last updated
3 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [177Lu]Lu-PSMA I&T and Stereotactic Radiotherapy in people with Prostate 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 23 inclusion and 16 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: looking for participants now, 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?

Contact Oriana Nanni (+390543739100, cc.ubsc@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month PSA (Prostate-Specific Antigen)-progression-free survival (PSA-PFS) (time frame: 12-months). 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 NCT05893381.

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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