A Study of Proton Radiation Divided into Fewer Doses for Low Risk Prostate Cancer

Overview

Información sobre este estudio

The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

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

  • Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization
  • History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization
  • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material
    • Gleason score must be in the range of 2-6
    • > 6 cores are strongly recommended
  • PSA values < 10 ng/ml within 90 days prior to randomization
    • Either done prior to biopsy or at least 21 days after prostate biopsy
  • Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.)
    • Staging must be done by treating investigator
  • No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative
  • Must be at least 18 years old
  • ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization
  • IPSS score < 16
  • Must give IRB approved, study specific, informed consent
  • Must complete all mandatory tests listed in section 4.0 within the specified time frames
  • Must be able to start treatment within 56 days of randomization

Exclusion Criteria

  • Previous prostate cancer surgery to include prostatectomy, hyperthermia and cryosurgery
  • Previous pelvic radiation for prostate cancer
  • Androgen deprivation therapy prior to radiation is allowed 
    • It is not acceptable if continued during radiation or as adjuvant therapy
  • Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis
  • Prior systemic chemotherapy for prostate cancer
  • History of proximal urethral stricture requiring dilatation
  • Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, clopidogrel bisulfate (Plavix)or equivalent) unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement
  • Any major medical, addictive or psychiatric illnesses which would affect the consent process, the completion of treatment and/or interfere with follow-up
    • Consent by legal authorized representative is not permitted in this study
  • Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival
    • Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed

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.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Carlos Vargas, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales