Prostate cancer
Conditions
Interventions
Product Name: [177Lu]Lu-PSMA-I&T
Pharmaceutical Form: Injection/infusion
INN or Proposed INN: lutetium (177Lu) zadavotide guraxetan
CAS Number: 2447131-70-4
Other descriptive name: [177Lu]Lu-PSMA- I&T
Sponsors
Medical University of Vienna
Medical University of Vienna
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Patients must be adults between 18 and 80 years of age. • Patients with BCR after RP and RT with a PSA doubling-time (DT) of = 12 months. • No hormonal therapy within the last 12 months or recovered testosterone levels. • PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1). • 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
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 one year. - 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: Primary objective: •Evaluate the prostate specific antigen (PSA) response to [177Lu]Lu-PSMAI&T-RLT •Assess therapy toxicity of systemic PSMA-RLT. ;Secondary Objective: Secondary objective: •Estimate duration of PSA response and imaging response to [177Lu]Lu-PSMAI&T-RLT as well as their stability. •Analyze androgen-deprivation therapy (ADT)- and treatment-free survival •Determine patient’s quality of life under the systemic [177Lu]Lu-PSMAI&T-RLT using the questionnaires: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) and Functional Assessment of Cancer Therapy–Prostate total score (FACT-P). ;Primary end point(s): - Response to the PSMA-RLT in terms decline of > 50% of PSA baseline value. - Toxicity as reflected by pathological decline of values of blood picture, kidney and liver functions from baseline levels assessed by CTCAE (v5.0) ;Timepoint(s) of evaluation of this end point: One and a half years after the start of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time (in weeks) to PSA progression (25% above pre-PSMA-RLT nadir) after completion of therapy - Imaging-progression free survival, defined as appearance of > 2 new lesions or increase in PSMA uptake or tumor PET volume by 30% or more. - Duration (in weeks) of treatment-free survival, defined as time from last PSMA-RLT to first PCa-directed therapy. - Duration (in weeks) of ADT-free survival, defined as time from last PSMA-RLT to first ADT administration. ADT will be administered in a case of progression; either PSA or imaging, as defined above. - Descriptive analysis of QoL from the questionnaires: FACT-P, EORTC QLQ. - Assessment of general healthcare costs for every patient during the entire study time. ;Timepoint(s) of evaluation of this end point: One and a half years after the start of the study | — |
Countries
Austria
Contacts
Public ContactCoordination Center-Clinical Study
Medical University of Vienna
Outcome results
None listed