Neoadjuvant PSMA-RLT in Oligometastatic PCa

NCT06259123 | Recruiting Phase 2

• 2 other identifiers: 1944/20222022-004115-92
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

[177Lu]Lu-PSMAI&T; Oligometastatic prostate cancer; Radical prostatectomy; Therapy toxicity

Outcome Measures

Primary Outcomes (1)

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

  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).

  12 months

Secondary Outcomes (7)

• PSA response to neoadjuvant PSMA-RLT and radical prostatectomy

  24 months

• Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy

  24 months

• Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy,

  24 months

• Estimate time to castration-resistant prostate cancer

  24 months

• Evaluate pathologic response at radical prostatectomy

  24 months

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

[177Lu]Lu-PSMA I&T DRUG

2 cycles of 5 GBq \[177Lu\]Lu-PSMA I\&T at 6-week intervals prior radical prostatectomy for patients with oligometastatic prostate cancer

Also known as: PSMA-RLT

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Sazan Rasul, PhD

CONTACT

004314040058742; sazan.rasul@meduniwien.ac.at

Shahrokh F. Shariat, Professor

CONTACT

004314040026150; shahrokh.shariat@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician and post-doctoral researcher

Model Details: Prospective single-center phase II study

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: February 14, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For 2 years after the end of the trail

Locations

AU (1)