A Study to Evaluate the Safety and Effectiveness of Hypofractionation Proton Beam Therapy in Patients who have Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-009528
    • Rochester, Minnesota: 15-009528
    NCT ID: NCT02874014
    Sponsor Protocol Number: MC1651

About this study

The purpose of this study is to evaluate the safety and effectiveness of a moderate hypofractionation regimen of proton beam therapy with same time treatment of the prostate, seminal vesicles, and the regional pelvic nodes  for patients who have clinically localized, high risk or unfavorable intermediate risk prostate cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Males
  • Age ≥ 18 years
  • Histological confirmation of adenocarcinoma of the prostate within 6 months of study enrollment
    • Clinical stage T1-2 N0 M0, Gleason Score 7, Prostate Specific Antigen (PSA) 20-100 ng/mL
    • Clinical stage any T N0 M0, Gleason Score 8-10, PSA ≤ 100 ng/mL
    • Clinical stage T3-4 N0 M0, any Gleason Score, PSA ≤ 100 ng/mL
    • Clinical stage T1-2 N0 M0, Gleason Score 4+3, PSA 10-20 ng/mL
  • Zubrod performance score (PS) ≤ 1
  • Total bilirubin, aspartate aminotransferase, alkaline phosphatase, and serum creatinine: < 2 x upper normal limit
  • Signed informed consent

Exclusion Criteria

  • Any known nodal (N1) or distant metastasis (M1)
  • Previous androgen deprivation therapy lasting more than 6 months
  • History of inflammatory bowel disease
  • Presence of a hip prosthesis
  • Prior pelvic radiotherapy or prostatectomy
  • Prior or concurrent antineoplastic agents (chemotherapy)
  • Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer
  • Inability to start the protocol treatment within 1 month after study enrollment
  • Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

C Choo, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

C Choo, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20260182

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