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NCT03294889Recrutement en cours

ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer

Résumé

The main objective of the phase I/II trial is to determine the safety and efficacy of a single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.

Critères d'inclusion

• Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures • Histologically confirmed adenocarcinoma of the prostate without small cell features • Tumor clinical stage cT1c-2c, pN0 or cN0, M0, according to UICC TNM 2009 • MRI staging must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c • Gleason score at biopsy 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2) • PSA ≤15 ng/ml • WHO performance status 0-1 • International Prostate Symptom Score ≤ 10 (alpha blockers allowed) • MRI-based volume estimation of prostate gland ≤ 70 cc • Patient agrees not to father a child during trial treatment and during 6 months thereafter

Critères d'exclusion

• Tumor clinical stage cT3a-3b or T4 • Evidence of T3a, T3b or T4 disease as assessed by MRI • Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies. • Significant tumor on the transitional zone as assessed by MRI • Gleason at biopsy ≥ 4+3 • Androgen deprivation therapy or products known to affect PSA levels • Impossibility to implant Calypso beacons • History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of curatively treated localized non-melanoma skin cancer • Prior pelvic radiotherapy • Previous surgery for prostate cancer • Previous transurethral resection of the prostate (TURP) (\< 12 weeks before registration) • Hip prosthesis • Severe or active co-morbidity likely to impact on the advisability of SBRT • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications

Contacts

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

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Statut
Recrutement en cours
Phase
Phase 1 · Phase 2
Type d'étude
Interventionnelle
Pays
Suisse
Promoteur
University Hospital, Geneva(Autre)
N° de protocole
2017-01236
Pathologies
Prostate Cancer
Interventions
Radiothérapie

Traitements évalués

  • Stereotactic body radition (SBRT)

Collaborateurs

Humanitas Hospital, Italy, University of Zurich, Kantonsspital Graubünden

Lieux · 1

  • Geneva, SuisseUniversity Hospital of GenevaRecrute dans ce centre

Au total, dans le monde, le seul centre listé au registre recrute.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 14 mai 2020).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

Autres identifiants

  • 2017 · financement NIH

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.