JOURNAL ONKOLOGIE – STUDIE

Neoadjuvant PSMA-RLT in Oligometastatic PCa

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06259123

Studienbeginn:
Februar 2024

Letztes Update:
15.02.2024

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

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Medical University of Vienna

Collaborator:
-

Kontakt

Sazan Rasul, PhD
Kontakt:
Phone: 004314040058742
E-Mail: sazan.rasul@meduniwien.ac.at» Kontaktdaten anzeigen

Shahrokh F. Shariat, Professor
Kontakt:
Phone: 004314040026150
E-Mail: shahrokh.shariat@meduniwien.ac.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Sazan Rasul, PhD
Phone: 004314040058742
E-Mail: sazan.rasul@meduniwien.ac.at

Shahrokh F. Shariat, Professor
Phone: 004314040026150
E-Mail: shahrokh.shariat@meduniwien.ac.at» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy (Time Frame - 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:

1. PSA response to neoadjuvant PSMA-RLT and radical prostatectomy (Time Frame - 24 months):
in term of PSA decline of ≥ 50% from baseline value

2. Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy (Time Frame - 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.

3. Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy, (Time Frame - 24 months):
estimate the time until the start of any therapy- and androgen deprivation therapy

4. Estimate time to castration-resistant prostate cancer (Time Frame - 24 months):
estimate the time until no PSA response in terms of PSA decline to androgen deprivation therapy

5. Evaluate pathologic response at radical prostatectomy (Time Frame - 24 months):
measured as rates of pathologic complete response, minimal residual disease, pT3 disease, positive surgical margins, and lymph node metastasis.

6. Quantification of circulating free tumor DNA (ctDNA) (Time Frame - 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.

7. Assess quality of life under the systemic PSMA-RLT (Time Frame - 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).

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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