Actively Recruiting
Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2025-12-03
70
Participants Needed
2
Research Sites
457 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with prostate cancer having 1-3 asymptomatic metastatic lesions 5.0 cm or < 250 cm3 documented by CT/MRI or whole-body MRI
- PSMA-PET/CT positive scan matching lesions on baseline imaging
- Primary tumor treated with surgery and/or radiation; prior salvage radiation allowed
- Diagnostic PET/CT PSMA SUV max 3
- Histologic confirmation of cancer (primary or metastatic)
- Prostate-specific antigen (PSA) between 0.2 and 50 ng/mL and testosterone 125 ng/dL
- PSA doubling time less than 15 months
- Patients unwilling or unfit for androgen deprivation therapy (ADT)
- Prior systemic therapy and/or ADT allowed
- Age 18 years or older
- Informed consent given
- Eastern Cooperative Oncology Group performance status 0 to 2
- Life expectancy of at least 6 months
- Normal organ and marrow function as defined by blood counts and liver/kidney tests
- Use of highly effective contraception during treatment and for 6 months after last dose
- Patients and partners must use two acceptable birth control methods including a condom during study and for 6 months after treatment
You will not qualify if you...
- More than 3 years of ADT or ADT received within 6 months before enrollment
- PSMA-PET/CT scan older than 3 months
- Spinal cord compression or at risk of spinal cord compression
- Suspected lung or liver metastases
- Bone metastasis in femoral bone
- Previous radiation therapy on metastatic site
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for certain drugs) prior to study
- Participation in another trial with investigational drugs within 30 days
- Any condition making participation unsafe or unsuitable
- Known brain metastases
- Allergic reactions to 177Lu-PSMA or similar agents
- Uncontrolled illnesses such as infection, heart failure, unstable angina, arrhythmias, or psychiatric issues
- Unable to lie flat or tolerate stereotactic ablative radiotherapy
- Other cancers within past 3 years except treated basal cell carcinoma
- Known HIV infection
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UO Medicina Nucleare, AUSL della Romagna
Cesena, FC, Italy, 47521
Actively Recruiting
2
UO Medicina Nucleare, IRCCS IRST
Meldola, FC, Italy, 47014
Actively Recruiting
Research Team
O
Oriana Nanni
CONTACT
B
Bernadette Vertogen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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