Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
10 participants
INTERVENTIONAL
2024-02-01
2027-06-30
Brief Summary
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Ten patients with oligometastatic primary PCa diagnosed using \[68Ga\]Ga-PSMA-11 PET-CT/MRI imaging will be included in this study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oligometastatic prostate cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging
Patients with 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 will receive 2 cycles of 5 GBq \[177Lu\]Lu-PSMA I\&T at 6-week intervals prior radical prostatectomy.
[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
Interventions
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[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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
MALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Sazan Rasul, MD, PhD
Physician and post-doctoral researcher
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-004115-92
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1944/2022
Identifier Type: -
Identifier Source: org_study_id
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