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L'essai clinique NCT04319783 (DECREASE) pour Carcinome de la Prostate Avancé, Cancer de la prostate, PSA, Cancer de la prostate résistant à la castration est actif, ne recrute pas. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA (DECREASE) Phase II 65

Actif, ne recrute pas
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT04319783 (DECREASE) est conçu pour étudier le traitement de Carcinome de la Prostate Avancé, Cancer de la prostate, PSA, Cancer de la prostate résistant à la castration. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : actif, ne recrute pas. L'étude a débuté le 2 juin 2021 et vise à recruter 65 participants. Dirigée par Trans Tasman Radiation Oncology Group, l'étude devrait être terminée d'ici le 1 juin 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 21 août 2025.
Résumé succinct
Darolutamide is a drug that has a proven survival benefit in non-metastatic (M0) castrate resistant prostate cancer when using conventional imaging. However, it is estimated that >90% of patients have disease apparent when using PSMA PET. This study investigates the use of local consolidation radiotherapy in this cohort of men.
Description détaillée
This study explores the use of local consolidation therapy in the setting of Darolutamide in the initial diagnosis of metastatic castrate resistant prostate cancer (mCRPC). In the chemotherapy naïve mCRPC setting, the pattern of disease is of limited volume metastases (1-5) in 34%-40% of cases. As progression at known sites of macroscopic disease is the predominant cause of failure on systemic therapies, local consol...Afficher plus
Titre officiel

Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

Pathologies
Carcinome de la Prostate AvancéCancer de la prostatePSACancer de la prostate résistant à la castration
Autres identifiants de l'étude
  • DECREASE
  • TROG 19.06
  • U1111-1242-9233 (Autre Identifiant) (UTN- World Health Organisation)
Numéro NCT
NCT04319783
Date de début (réel)
2021-06-02
Dernière mise à jour publiée
2025-08-21
Date de fin (estimée)
2026-06
Inscription (estimée)
65
Type d'étude
Interventionnel
PHASE
Phase II
Statut
Actif, ne recrute pas
Mots clés
Darolutamide
Consolidation Radiotherapy
PSA
PSMA PET
Prostate Cancer
Advanced Prostate Cancer
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalDarolutamide
Darolutimide 600mg BD
Darolutamide
Darolutamide alone
ExpérimentalLocal consolidation Radiotherapy + Darolutamide
Darolutimide 600mg BD + local consolidative radiotherapy, with a biological equivalent dose of 30Gy/10fx or greater if delivered with SABR. SABR is the preferred treatment approach, however conventional radiotherapy is acceptable. To up to 5 sites of disease
Darolutamide
Darolutamide alone
Radiothérapie
Darolutamide + Consolidation Radiotherapy
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Undetectable PSA at 12 months
Undetectable PSA at 12 months
12 months
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Radiological progression free survival
Radiological progression free survival
36 months
Distribution of disease on baseline PSMA-PET/CT imaging
Distribution of bone, nodal, visceral and recurrent primary disease on PSMA-PET/CT
36 months
Biochemical progression free survival
Biochemical progression free survival
36 months
Treatment related adverse event
Treatment related adverse events (CTCAE v 5.0)
36 months
Overall survival
Overall survival
36 months
Patterns of disease on PSMA PET/CT after 12 weeks of commencing Darolutamide, and at time of disease progression
PSMA avid disease at irradiated site / unirradiated site / bone / local / nodal / visceral
3 months
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Homme

  • ≥ 18 years of age and provided written Informed Consent

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features

  • Castration-resistant prostate cancer, defined as at least 2 consecutive PSA rises obtained at least 1 week apart in the setting of castrate testosterone levels

  • Castrate level of serum testosterone (<1.7 nmol/l \[50 ng/dl\]) on gonadotrophin - releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy

  • A baseline PSA level of at least 1ng per millilitre and a PSA doubling time of 10 months or less

  • Adequate bone marrow reserve and organ function Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions; At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions:

    • Local recurrence within the prostate gland or prostate bed
    • Regional lymph node disease (below the aortic bifurcation)
    • Extra-pelvic lymph node, bone or soft tissue metastatic disease

  • Patients with detectable metastases or a history of metastatic disease on conventional imaging
  • Prior treatment with second-generation androgen receptor (AR) antagonists, CYP17 enzyme inhibitors or oral ketoconazole
  • Use of oestrogens or 5-α reductase inhibitors or anti-androgens within 28 days before randomisation
  • Use of systemic corticosteroid with a dose greater than the equivalent 10 mg of prednisone/day within 28 days before randomisation
  • Radiotherapy within 12 weeks prior to randomisation
  • Initiation of treatment with an osteoclast-targeted therapy to prevent skeletal-related events within 12 weeks before randomisation
  • Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV
  • Uncontrolled hypertension
  • Prior malignancy
  • Gastrointestinal disorder or procedure that expects to interfere significantly with the absorption of study treatment
  • Unable to swallow study medications and comply with study requirements
Trans Tasman Radiation Oncology Group logoTrans Tasman Radiation Oncology Group
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16 Centres de l'étude dans 2 pays

New South Wales

St Vincent's Hospital, Darlinghurst, New South Wales, 2101, Australia
GenesisCare Hurstville, Hurstville, New South Wales, 2220, Australia
GenesisCare North Shore, Saint Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle, Waratah, New South Wales, 2298, Australia

Queensland

Royal Brisbane and Women's Hospital, Herston, Queensland, 4006, Australia
Princess Alexandra Hospital (ROPART), Raymond Terrace, Queensland, 4101, Australia
Princess Alexandra Hospital (ROPAIR), Woolloongabba, Queensland, 4102, Australia

South Australia

Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia

Tasmania

Royal Hobart Hospital, Hobart, Tasmania, 7000, Australia

Victoria

Peter MacCallum Cancer Centre, Bendigo, Bendigo, Victoria, 3550, Australia
Peter MacCallum Cancer Centre, Box Hill, Box Hill, Victoria, 3128, Australia
Peter MacCallum Cancer Centre, Parkville, Melbourne, Victoria, 3002, Australia
Icon Cancer Centre Epworth, Richmond, Victoria, 3121, Australia
Western Health, St Albans, Victoria, 3021, Australia

Western Australia

GenesisCare Fiona Stanley Hospital, Murdoch, Western Australia, 6150, Australia
National Cancer Centre Singapore, Singapore, 168583, Singapore