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Clinical Trials in Austria / NCT06259123
Recruiting Phase 2

Neoadjuvant PSMA-RLT in Oligometastatic PCa

NCT06259123 · tracked via the Priya Life Science Austria tracker
Sponsor
Medical University of Vienna
Phase
Phase 2
Started
2024-02-01
Last updated
2024-02-15

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

[177Lu]Lu-PSMA I&T →

[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

Study 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
MALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy — 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).

Trial sites (1)

FacilityCityRegionStatus
Medical University of Vienna Vienna Austria Recruiting

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Other trials for the same condition

Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer Recruiting
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study Active, not recruiting
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) Recruiting
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06259123 on ClinicalTrials.gov ↗ ← All trials in Austria