Neoadjuvant PSMA-RLT in Oligometastatic PCa

Summary

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.

Eligibility

Inclusion Criteria:

* Oligometastatic PCa diagnosed using \[68Ga\]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases
* 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

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 the duration of the trial.
* Nonmetastatic PCa on \[68Ga\]Ga-PSMA-11 imaging
* \>5 osseous metastases on \[68Ga\]Ga-PSMA-11 imaging
* Visceral metastases, apart from lungs
* Age \> 75 years.
* Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies.
* 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

Conditions2

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