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Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

NCT01950351 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2025-12-22

No results posted yet for this study

Summary

This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

Conditions

  • Stage I Prostate Adenocarcinoma AJCC v7
  • Stage II Prostate Adenocarcinoma AJCC v7

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

RADIATION

Proton Beam Radiation Therapy

Undergo proton beam radiation therapy

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Steven J Frank · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-10
Primary Completion
2028-06-01
Completion
2028-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01950351 on ClinicalTrials.gov