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RECRUITINGPhase 2INTERVENTIONAL

Neoadjuvant PSMA-RLT in Oligometastatic PCa

Neoadjuvant [177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Oligometastatic Prostate Cancer Diagnosed Using [68Ga]Ga-PSMA-11 PET Imaging Followed by Radical Prostatectomy: A Prospective Phase II Pilot Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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, platelet count at least 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 willing to sign a consent form Form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

[177Lu]Lu-PSMA I&T

2 cycles of 5 GBq \[177Lu\]Lu-PSMA I\&T at 6-week intervals prior radical prostatectomy for patients with oligometastatic prostate cancer

Locations (1)

Medical University of Vienna
Vienna, Austria