Neoadjuvant PSMA-RLT in Oligometastatic PCa

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: [177Lu]Lu-PSMA I&T

• Registration Number: NCT06259123
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-25
• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2027-01
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oligometastatic prostate cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging	[177Lu]Lu-PSMA I&T	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.

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
PSA response to neoadjuvant PSMA-RLT and radical prostatectomy	24 months	in term of PSA decline of ≥ 50% from baseline value
Evaluate pathologic response at radical prostatectomy	24 months	measured as rates of pathologic complete response, minimal residual disease, pT3 disease, positive surgical margins, and lymph node metastasis.
Estimate time to castration-resistant prostate cancer	24 months	estimate the time until no PSA response in terms of PSA decline to androgen deprivation therapy
Assess quality of life under the systemic PSMA-RLT	24 months	using the questionnaires: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) and Functional Assessment of Chronic Illness Therapy (FACT-P).
Quantification of circulating free tumor DNA (ctDNA)	24 months	enumeration of circulating tumor cells (CTCs) during the study period, molecular changes measured in liquid biopsy markers and tissue specimens following PSMA-RLT and radical prostatectomy and during follow-up.
Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy	24 months	in terms of disappearance of PSMA-avid lesions and/or size regression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1.
Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy,	24 months	estimate the time until the start of any therapy- and androgen deprivation therapy

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria