Patients with mCRPC, PSMA expressing, clinical and/or radiological progressive castrate resistant metastatic prostate cancer without any previous disease related systemic therapy.
Conditions
Interventions
Product Name: Lutetium-177-PSMA-617
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: [177Lu]Lu-DOTA-PSMA-617
Other descriptive
Sponsors
Radboudumc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male aged 18 or older with metastatic adenocarcinoma of the prostate; 2. Metastatic castrate-resistant prostate cancer without any previous treatments; 3. Progressive disease with rising PSA on 3 consecutive measurements, and PSA = 20 ng/mL; 4. Target or non-target lesions > 1.5 cm in diameter according to RECIST 1.1; 5. Significant PSMA avidity on 68Ga/18F-PSMA PET/CT 6. ECOG Performance status 0 to 2; 7. Adequate renal function; 8. Adequate bone marrow function; 9. Adequate liver function; 10. Willing and able to comply with all study requirements; 11. Signed, written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Known brain metastasis; 2. Site(s) of disease that show minimal PSMA expression; 3. Sjogren's syndrome; 4. Prior treatment with 177Lu-PSMA-617; 5. Prior chemotherapy or androgen receptor inhibition therapy; 6. Contraindications to the use of corticosteroid treatment; 7. Active malignancy other than prostate cancer, except for patients with basal or squamous skin cancer, and carcinoma in situ of the bladder; 8. Imminent spinal cord compression; 9. Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety; 10. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse; 11. Any condition which, in the opinion of the investigator, would preclude participation in this trial; 12. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of this first line 177Lu-PSMA RLT study is to evaluate the clinical efficacy in castration resistant metastatic prostate cancer. Secondary aims are to assess the progression free survival (radiographic, clinical or PSA progression free survival), the response to 177Lu-177 PSMA RLT (RECIST 1.1, metabolic, biomarkers), the safety and tolerability, the health-related quality of life assessment and pain assessment, and the overall survival.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the therapy response defined as decline of PSA value of > 50%. ;Timepoint(s) of evaluation of this end point: 24 months after last radioligand therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Netherlands
Contacts
Public ContactMichel de Groot
Radboudumc
Outcome results
None listed