Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA \> nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
2 cycles (3 GBq in first cycle and 6 GBq in the second cycle) of \[177Lu\]Lu-PSMAI\&T radioligand therapy at 6-week intervals
Medical University of Vienna
Vienna, Austria
RECRUITINGPSA response
in term of PSA decline of ≥ 50% from baseline value
Time frame: 12 months
Emergence of therapy toxicity
in terms of pathological (Grade 3) reduction of values of blood count (hemoglobin decreased \<8.0 g/dL; \<4.9 mmol/L; \<80 g/L; platelet count decreased \<50,000 - 25,000/mm3; \<50.0 - 25.0 x 10e9 /L and white blood cell decreased \<2000 - 1000/mm3; \<2.0 - 1.0 x 10e9 /L. ), kidney (creatinine increased \> 3.0 x baseline or \>3.0 - 6.0 x upper limit of normal (UNL)) and liver functions (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and GGT increased \>5.0 - 20.0 x ULN if baseline was normal or \>5.0 - 20.0 x baseline if baseline was abnormal; albumin \<2 g/dL or \<20 g/L; bilirubin increased \>3.0 - 10.0 x ULN if baseline was normal or \>3.0 - 10.0 x baseline if baseline was abnormal and lactate dehydrogenase increased \> ULN.), assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: 12 months
Time to PSA value progression
to evaluate progression free survival
Time frame: 18 months
androgen deprivation therapy- and other treatment-free survival
analyze the time until the start of androgen deprivation therapy
Time frame: 18 months
Evaluation of life quality of the treated patients
Using the questionnaires: FACT-P, EORTC QLQ
Time frame: 18 months
Assess time to imaging progression
In terms of appearance of new PSMA-avid lesions and/or size progression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1.
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Time frame: 18 months
Quantification of circulating free tumor DNA
Quantification of circulating free tumor DNA (ctDNA), enumeration of circulating tumor cells (CTCs) before and following \[177Lu\]Lu-PSMAI\&T-RLT and analyse molecular changes in liquid biopsy markers following \[177Lu\]Lu-PSMAI\&T-RLT.
Time frame: 18 months