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Neoadjuvant PSMA-RLT in Oligometastatic PCa

RecruitingPhase 2Ages 18 Years - 75 YearsMaleMedical University of Vienna
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Oligometastatic PCa diagnosed using \[68Ga\]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with โ‰ค5 osseous metastases and/or M1c โ‰ค3 lung metastases * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 * Patients must have adequate bone marrow reserve: WBC โ‰ฅ1.5 x 109 /L, Platelets โ‰ฅ100 x 109 /L and Haemoglobin โ‰ฅ9 g/dL. * Patients must have adequate renal function with eGFR โ‰ฅ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of โ‰ฅ2.5 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
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What it tests

  • [177Lu]Lu-PSMA I&T
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Where

1 site
Medical University of Vienna
Vienna, Austria
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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