Actively Recruiting
Neoadjuvant PSMA-RLT in Oligometastatic PCa
Led by Medical University of Vienna · Updated on 2024-02-15
10
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant PSMA-RLT in Oligometastatic PCa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Oligometastatic prostate cancer diagnosed by [68Ga]Ga-PSMA-11 imaging with M1a and/or M1b positive and 5 or fewer bone metastases and/or M1c with 3 or fewer lung metastases
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate bone marrow function with WBC 1.5 x 10^9/L, platelets 100 x 10^9/L, and hemoglobin 9 g/dL
- Adequate kidney function with eGFR 50 mL/min/1.73 m^2 and albumin level 2.5 g/dL
- Ability to sign informed consent form
You will not qualify if you...
- Participation in another interventional trial
- Severe cancer or medical conditions limiting life expectancy beyond the trial duration
- Nonmetastatic prostate cancer on [68Ga]Ga-PSMA-11 imaging
- More than 5 bone metastases on [68Ga]Ga-PSMA-11 imaging
- Visceral metastases except for lungs
- Age over 75 years
- Current or prior androgen deprivation therapy with agonists or antagonists
- Clinically significant somatic or psychiatric diseases affecting study objectives or assessments
- Complete urinary outflow obstruction or severe unmanageable urinary incontinence
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
S
Sazan Rasul, PhD
CONTACT
S
Shahrokh F. Shariat, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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