Neoadjuvant PSMA-RLT in Oligometastatic PCa
Recruiting · NCT06259123 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of Vienna
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Medical University of Vienna - Vienna, Austria