Prostate Cancer
Conditions
Interventions
Product Name: [177Lu]Lu-PSMA-I&T
Pharmaceutical Form: Infusion
INN or Proposed INN: lutetium (177Lu) zadavotide guraxetan
CAS Number: 2447131-70-4
Other descriptive name: [177Lu]Lu-PSMA-I&T
Concentrat
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Patients must be adults between 18 and 75 years of age. - Oligometastatic PCa diagnosed using [68Ga]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with =5 osseous metastases and/or M1c =3 lung metastases - Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 - Patients must have adequate bone marrow reserve: WBC =1.5 x 109 /L, Platelets =100 x 109 /L and Haemoglobin =9 g/dL. - Patients must have adequate renal function with eGFR = 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of =2.5 g/dL. - Patients must be able to sign Informed Consent Form. 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Concomitant participation in any other interventional trial. - Concurrent severe oncologic and medical conditions that result in patients not having a life expectancy of longer than the duration of the trial. - Nonmetastatic PCa on [68Ga]Ga-PSMA-11 imaging - more than 5 osseous metastases on [68Ga]Ga-PSMA-11 imaging - visceral metastases, apart from lungs - Age > 75 years. - Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies. - Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study. - Complete urinary out-flow obstruction or severe unmanageable urinary incontinence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze safety and toxicity of neoadjuvant PSMA-RLT and radical prostetectomy ;Secondary Objective: - PSA complete response to PSMA-RLT followed by radical prostetectomy - Imaging response and stability - Therapy-free survival after radical prostetectomy - Androgen depriviation therapy-free survival after radical prostetectomy - Time to castration-resistant prostate cancer - Quantification of circulating free tumor DNA (ctDNA) following PSMA-RLT and radical prostetectomy and during follow up. - Enumeration of circulating tumor cells (CTCs) during the study period - Molecular changes measured in liquid biopsy markers and tissue specimens following PSMARLT and radical prostetectomy - Feasibility of radical prostetectomy after PSMA-RLT - Patient’s quality of life under the systemic PSMA-RLT using the questionnaires: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) and Functional Assessment of Chronic Illness Therapy (FACT-P).;Primary end point(s): Absolute rates of toxicity events defined as pathological decline of values of blood picture, kidney and liver functions from baseline levels assessed by CTCAE (v5.0). Absolute rates of periand postoperative (6 weeks) complications associated with radical prostetectomy assessed using Clavien-Dindo classification;Timepoint(s) of evaluation of this end point: After completion of both types of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rates of PSA response to the PSMA-RLT in terms of PSA decline of > 30% from baseline prior to radical prostetectomy. - Imaging response based on RECIST v1.1 and modified PET Response Criteria in Solid Tumors (PERCIST) 1.0 considered as: complete response with disappearance of all target and PSMA-avid lesions or partial response with at least a 30% decrease in the sum of the longest diameter and decrease of summed SUVmean or total tumor volume of =30% of target lesions from baseline images on [68Ga]Ga-PSMA-11 following PSMA-RLT. - Rates of complete PSA response defined as PSA 50% above the nadir or administration of secondary therapies. - Therapy free survival after 2nd PSMA-RLT and radical prostetectomy, defined as time (months) from radical prostetectomy to first salvage PCa-directed radiation therapy, such as second-line systemic therapy and/or salvage radiotherapy. - AFS after 2nd PSMA-RLT and RP, defined as time (months) from radical prostetectomy to first administration of ADT therapy - Time from radical prostetectomy to castration-resistant prostate cancer (according to the EAU criteria [5]) - Pathologic response at radical prostetectomy, measured as rates of pathologic complete response, minimal residual disease (=5mm), pT3 disease, positive surgical margins, and lymph node metastasis. - Molecular changes measured in liquid markers and tissue specimens following PSMA-RLT and radical prostetectomy - ctDNA quantification and ciculating tumor cell enumeration - Determine patient’s quality of life under the systemic PSMA-RLT using the questionnaires: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) and Functional Assessment of Chronic Illness Therapy (FACT-P).;Timepoint(s) of evaluation of this end point: After 2 years | — |
Countries
Austria
Contacts
Public ContactCoordination Center Clinical Study
Medical University of Vienna
Outcome results
None listed