RecruitingPhase 2NCT06259123

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


Sponsor

Medical University of Vienna

Enrollment

10 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of targeted radiation therapy called PSMA radioligand therapy (PSMA-RLT) as a treatment before the main surgery or radiation for prostate cancer that has spread to a small number of sites (called oligometastatic prostate cancer). **You may be eligible if...** - You have prostate cancer that has spread to a limited number of sites (up to 5 bone spots or up to 3 small lung spots), confirmed by a special PSMA scan - You are in good general health (ECOG score 0 or 1) - Your blood counts and kidney function meet minimum requirements - You are 75 years old or younger - You have not previously received hormone-blocking therapy (androgen deprivation therapy) **You may NOT be eligible if...** - You are participating in another interventional clinical trial - You have more than 5 bone metastases or spread to organs other than the lungs - You previously received androgen deprivation therapy - You have severe urinary problems or complete urinary blockage - You have serious psychiatric or medical conditions that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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NCT06259123


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