NCT02874014CompletedPhase 2
Hypofractionation Proton Beam Therapy With Concurrent Treatment of Prostate and Pelvic Nodes for Prostate Cancer
Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer
Source: ClinicalTrials.gov · Last updated 22 Aug 2025
Brief summary (registry, in English)
The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180 centigray/fraction) simultaneously. The overall treatment time is 5 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 17 Aug 2016
- Start date
- 25 Jul 2016
- Primary completion date
- 8 Feb 2021
- Lead sponsor
- Mayo Clinic
- Diseases
- Prostate cancer
- NCT number
- NCT02874014
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 56
- From 25 Jul 2016 to the primary completion date, 8 Feb 2021
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous androgen deprivation therapy lasting more than 6 months
- 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.
Other illness
- History of inflammatory bowel disease
- Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up
Other
- Any known nodal (N1) or distant metastasis (M1)
- Presence of a hip prosthesis
- Inability to start the protocol treatment within 1 month after study enrollment.
Who the study is looking for
- Male; 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, or Clinical stage Any T N0 M0, Gleason Score 8-10, PSA ≤ 100 ng/mL, or Clinical stage T3-4 N0 M0, any Gleason Score, PSA ≤ 100 ng/mL, or 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.