Neoadjuvant PSMA-RLT in Oligometastatic PCa

Medical University of Vienna

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: [177Lu]Lu-PSMA I&T

Study type: Interventional

Funder types: Other

Identifiers

NCT06259123

1944/2022

2022-004115-92 (EudraCT Number)

Details and patient eligibility

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Oligometastatic prostate cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging

Experimental group

Description:

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.

Treatment:

Drug: [177Lu]Lu-PSMA I&T