Neoadjuvant PSMA-RLT in Oligometastatic PCa

Official title

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

Overview

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.

Interventions

• Drug [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

Primary outcome measures

• Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy [Time frame: 12 months]

Secondary outcome measures (7)

• PSA response to neoadjuvant PSMA-RLT and radical prostatectomy [Time frame: 24 months]
• Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy [Time frame: 24 months]
• Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy, [Time frame: 24 months]
• Estimate time to castration-resistant prostate cancer [Time frame: 24 months]
• Evaluate pathologic response at radical prostatectomy [Time frame: 24 months]
• Quantification of circulating free tumor DNA (ctDNA) [Time frame: 24 months]
• Assess quality of life under the systemic PSMA-RLT [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Austria · 1 center

• Medical University of Vienna — Vienna

Identifiers

NCT: NCT06259123 · 1944/2022 · 2022-004115-92

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗