Your browser doesn't support javascript.
loading
LUNAR: a randomized Phase 2 study of 177 Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (clinical trial protocol).
Ma, Ting Martin; Czernin, Johannes; Felix, Carol; Alano, Rejah; Wilhalme, Holly; Valle, Luca; Steinberg, Michael L; Dahlbom, Magnus; Reiter, Robert E; Rettig, Matthew B; Cao, Minsong; Calais, Jeremie; Kishan, Amar U.
Afiliação
  • Ma TM; Department of Radiation Oncology, University of California, Los Angeles, CA, USA.
  • Czernin J; Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
  • Felix C; Physics and Biology in Medicine Interdepartmental Graduate Program, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Alano R; Department of Radiation Oncology, University of California, Los Angeles, CA, USA.
  • Wilhalme H; Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
  • Valle L; Department of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Steinberg ML; Department of Radiation Oncology, University of California, Los Angeles, CA, USA.
  • Dahlbom M; Department of Radiation Oncology, University of California, Los Angeles, CA, USA.
  • Reiter RE; Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
  • Rettig MB; Physics and Biology in Medicine Interdepartmental Graduate Program, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Cao M; Department of Urology, University of California, Los Angeles, CA, USA.
  • Calais J; Division of Hematology and Oncology, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Kishan AU; Department of Radiation Oncology, University of California, Los Angeles, CA, USA.
BJU Int ; 132(1): 65-74, 2023 07.
Article em En | MEDLINE | ID: mdl-36797449
ABSTRACT

OBJECTIVE:

To assess the efficacy of 177 Lu-PNT2002, a novel radiolabelled small molecule that binds with high affinity to prostate-specific membrane antigen (PSMA), in combination with stereotactic body radiotherapy (SBRT) to all sites of metastasis, vs SBRT alone, in men with oligorecurrent metastatic hormone-sensitive prostate cancer (mHSPC). PATIENTS AND

METHODS:

The 177 Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (LUNAR) trial is an open-label, randomized, stratified, two-arm, single-centre, Phase 2 trial to compare the efficacy and safety of neoadjuvant 177 Lu-PNT2002 plus SBRT vs SBRT alone in men with oligorecurrent mHSPC. Key eligibility criteria include one to five lesions identified on a PSMA positron emission tomography (PET)/computed tomography (CT) scan centrally reviewed by a board-certified nuclear medicine physician. Key exclusion criteria include castrate-resistant disease, de novo oligometastatic disease and receipt of androgen deprivation therapy (ADT) within 6 months of trial enrolment. The trial aims to enrol 100 patients who will be centrally randomized to one of the two treatment arms, in a 11 ratio. Patients in the control arm receive SBRT to all sites of disease. Patients in the experimental arm receive two cycles of neoadjuvant 177 Lu-PNT2002 (6.8 GBq) 6-8 weeks apart, followed by an interval PSMA PET/CT in 4-6 weeks and dose-adapted SBRT to all sites of disease 1-2 weeks later. The primary endpoint is progression-free survival. Secondary endpoints are radiographic and prostate-specific antigen-based progression, acute and late physician-scored toxicity, patient-reported quality of life, ADT-free survival, time to progression, overall survival, locoregional control, and duration of response. Enrolment in the study commenced in September 2022. RESULTS AND

CONCLUSIONS:

The addition of 177 Lu-PNT2002 to metastasis-directed therapy alone may potentially further forestall disease progression. The results of this Phase 2 trial will determine, for the first time in a randomized fashion, the added benefit of 177 Lu-PNT2002 to SBRT in patients with oligorecurrent mHSPC.
Assuntos
Palavras-chave
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Próstata / Neoplasias de Próstata Resistentes à Castração Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Humans / Male Idioma: En Revista: BJU Int Assunto da revista: UROLOGIA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Próstata / Neoplasias de Próstata Resistentes à Castração Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Humans / Male Idioma: En Revista: BJU Int Assunto da revista: UROLOGIA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos