LUTETIUM (177LU) ZADAVOTIDE GURAXETAN for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Patients must be adults ≥ 18 years of age."}
• {"criterion_text":"- Patients with BCR primarily treated with RP and patients with BCR primarily treated with RT with a PSA doubling-time (PSADT) of ≤ 12months."}
• {"criterion_text":"- No hormonal therapy within the last 12 months and/or recovered testosterone levels."}
• {"criterion_text":"- [68Ga]Ga-PSMA-11 PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1)."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1"}
• {"criterion_text":"- Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients must be able to sign Informed Consent Form."}

Exclusion criteria

• {"criterion_text":"- Concomitant participation in any other interventional trial."}
• {"criterion_text":"- Concurrent severe oncologic and medical conditions that result in patients not having a life expectancy of longer than one year."}
• {"criterion_text":"- Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study."}
• {"criterion_text":"- Complete urinary out-flow obstruction or severe unmanageable urinary incontinence."}

Primary endpoints

• {"endpoint_text":"- PSA response in term of PSA decline of ≥ 50% from baseline value.","definition_or_measurement_approach":"PSA decline measured from baseline; endpoint defined as a ≥50% decline from baseline value."}
• {"endpoint_text":"- Emerge therapy toxicity in terms of pathological reduction of values of blood count, kidney and liver functions from baseline levels assessed by CTCAE (v5.0).","definition_or_measurement_approach":"Toxicity assessed by changes from baseline in blood count, renal and liver function parameters, graded according to CTCAE v5.0."}

Austria

Earliest CTIS Part Ii Submission Date

19-11-2024

Latest Decision Or Authorization Date

19-09-2025

Processing Time Days

304

Number Of Sites

1

Number Of Participants

26

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria