Prospective single-center phase II study to evaluate the PSA, imaging and pathological response, as well as oncological outcomes of systemic radioligand therapy \[177Lu\]Lu-PSMAI\&T (PSMA-RLT) in patients planned for radical prostatectomy (RP) for oligometastatic prostate cancer (PCa) diagnosed using \[68Ga\]Ga-PSMA-11 PET examination. Ten patients with oligometastatic primary PCa diagnosed using \[68Ga\]Ga-PSMA-11 PET-CT/MRI imaging will be included in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
2 cycles of 5 GBq \[177Lu\]Lu-PSMA I\&T at 6-week intervals prior radical prostatectomy for patients with oligometastatic prostate cancer
Medical University of Vienna
Vienna, Austria
RECRUITINGIncidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy
Using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Furthermore, regular estimation of patient's ability to perform their usual everyday activities using Karnofsky performance status scale that ranges between a maximum of 100 percent (no restrictions) and 0 percent (death) and Eastern Cooperative Oncology Group Status scale that ranges from 0 (complete health) to 5 (death).
Time frame: 12 months
PSA response to neoadjuvant PSMA-RLT and radical prostatectomy
in term of PSA decline of ≥ 50% from baseline value
Time frame: 24 months
Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy
in terms of disappearance of PSMA-avid lesions and/or size regression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1.
Time frame: 24 months
Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy,
estimate the time until the start of any therapy- and androgen deprivation therapy
Time frame: 24 months
Estimate time to castration-resistant prostate cancer
estimate the time until no PSA response in terms of PSA decline to androgen deprivation therapy
Time frame: 24 months
Evaluate pathologic response at radical prostatectomy
measured as rates of pathologic complete response, minimal residual disease, pT3 disease, positive surgical margins, and lymph node metastasis.
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Time frame: 24 months
Quantification of circulating free tumor DNA (ctDNA)
enumeration of circulating tumor cells (CTCs) during the study period, molecular changes measured in liquid biopsy markers and tissue specimens following PSMA-RLT and radical prostatectomy and during follow-up.
Time frame: 24 months
Assess 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).
Time frame: 24 months