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Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy in Prostate Carcinoma

Overview

Información sobre este estudio

This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT) is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time points. The study will analyze the followings: 1. Change in CgA level at various pre-defined post-RT time points from the baseline, 2. Correlation between the extent of post-therapy CgA change and Gleason score of malignancy, 3. Correlation between the extent of post-therapy CgA change and treatment outcome.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Clinically localized prostate carcinoma, T1-T4 N0M0, any Gleason Score (Gleason Score 7 including those with T3 disease as well as ≤ T2c disease), any prostate-specific antigen (PSA), or Biochemical relapse with clinically suspicious (based on MRI or clinical examination) or biopsy-proven local recurrence in the prostatic fossa after a radical prostatectomy
  • ≥18 years old
  • Histologic diagnosis of prostate adenocarcinoma
  • Signed informed consent

Exclusion Criteria:

  • Biochemical relapse alone without clinically suspicious (i.e. no suspicious lesion on MRI of the prostatic bed) or biopsy-proven local recurrence in the prostatic fossa
  • Regional pelvic node metastasis (N1)
  • Distant metastasis (M1)
  • Concurrent or previous cytotoxic medications
  • Medical or psychological conditions that in the opinion of the investigator would not allow follow-up

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Chunhee Choo, M.D.

Cerrado para la inscripción

Contact information:

Adam Amundson

(507)293-1826

Amundson.Adam1@mayo.edu

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Bradford Hoppe, M.D., M.P.H.

Cerrado para la inscripción

Contact information:

Anna Harrell M.P.H.

(904)953-8183

Harrell.Anna@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20304540

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