Medical University of Vienna
Vienna, 1090, Austria
Location status: Recruiting
Location contact
Pawel Rajwa, MD
SUB_INVESTIGATOR
Sazan Rasul, PhD
CONTACT
Sazan Rasul, PhD
PRINCIPAL_INVESTIGATOR
Shahrokh F. Shariat, Professor
CONTACT
NCT Number: NCT06259123
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.
Interested in participating?
Request Info18 year–75 year
Male
Interventional
Phase 2
Vienna, 1090, Austria
Location status: Recruiting
Pawel Rajwa, MD
SUB_INVESTIGATOR
Sazan Rasul, PhD
CONTACT
Sazan Rasul, PhD
PRINCIPAL_INVESTIGATOR
Shahrokh F. Shariat, Professor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 cycles of 5 GBq [177Lu]Lu-PSMA I&T at 6-week intervals prior radical prostatectomy for patients with oligometastatic prostate cancer
Other names: PSMA-RLT
Time frame: 12 months
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: 24 months
in term of PSA decline of ≥ 50% from baseline value
Time frame: 24 months
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
estimate the time until the start of any therapy- and androgen deprivation therapy
Time frame: 24 months
estimate the time until no PSA response in terms of PSA decline to androgen deprivation therapy
Time frame: 24 months
measured as rates of pathologic complete response, minimal residual disease, pT3 disease, positive surgical margins, and lymph node metastasis.
Time frame: 24 months
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
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).
Contact information is provided by the study sponsor or research team.
Sazan Rasul, PhD
CONTACT
Shahrokh F. Shariat, Professor
CONTACT
Medical University of Vienna
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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