Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy

Overview

Acerca de este estudio

The purpose of this study is to determine if salvage stereotactic body radiotherapy (SBRT) is non-inferior to moderately hypofractionated radiation therapy (HFRT) regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) Grade 3 or higher within 2-years.

 

Elegibilidad para participar

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 at the time of surgery.
  • Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (AJCC Criteria 8th Ed.).
  • PSA post radical prostatectomy ≥ 0.1 and < 2.0 ng/mL within 90 days prior to enrollment, obtained at least 6 weeks after surgery.
  • ECOG performance status 0-2 assessed within 90 days of enrollment.
  • Patients must sign IRB approved study specific informed consent.
  • Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
  • Patients must be able to start treatment (ADT or radiation) within 120 days of study registration.
  • Patients must be at least 18 years old.

Exclusion Criteria: 

  • Previous pelvic radiation.
  • Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL.
  • Active rectal diverticulitis, Crohn’s disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn’s disease not affecting the rectum are allowed).
  • Prior systemic chemotherapy for prostate cancer.
  • History of proximal urethral stricture requiring dilatation.
  • Major medical, addictive, or psychiatric illness which in the investigator’s opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).           
  • History of myocardial infarction or decompensated CHF within the last 6 months.
  • On a transplant list.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/31/22. Questions regarding updates should be directed to the study team contact.

Ubicaciones 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.

Ubicación de Mayo Clinic Estado Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Timothy Malouff, M.D.

Inscripción abierta

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Investigador principal de Mayo Clinic

Jason Hayes, M.D.

Inscripción abierta

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

La Crosse, Wis.

Investigador principal de Mayo Clinic

Abigail Stockham, M.D.

Inscripción abierta

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Carlos Vargas, M.D.

Inscripción abierta

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Eau Claire, Wis.

Investigador principal de Mayo Clinic

Now Bahar Alam, M.D.

Inscripción abierta

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Albert Lea, Minn.

Investigador principal de Mayo Clinic

John Yeakel, M.D.

Inscripción abierta

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