[177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with prostate cancer and biochemical but not radio-morphological local recurrence after primary therapy with curative intent: A Prospective Phase II Study - PSMA-RLT in biochemically recurrent prostate cancer

Medical University of Vienna0 sites20 target enrollmentJanuary 31, 2023

Overview

No summary available.

Registry

who.int

Start Date

January 31, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•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:

•\- 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.