RECRUITING

Proton Radiation Therapy for the Treatment of Patients with High Risk Prostate Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.

Official Title

Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer

Quick Facts

Study Start:2021-02-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04725903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically confirmed high-risk prostate cancer fulfilling any one of the following criteria:
  2. * Gleason grade 8 or higher
  3. * cT3b (seminal vesicle involvement) or cT4
  4. * Prostate specific antigen \[PSA\] \> 20 (or PSA \>10 if on finasteride)
  5. * Clinically or pathologically positive regional lymph nodes within the inguinal, external iliac, internal iliac, obturator, peri-rectal, pre-sacral, common iliac, or lower para-oaortc (inferior to the L2-L3 interspace) basins
  6. * Zubrod performance status 0-2
  7. * Complete blood cell (CBC)/differential obtained within 90 days prior to registration on study
  8. * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
  9. * Platelets \>= 100,000 cells/mm\^3
  10. * Hemoglobin \>= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
  11. * Patient must be able to provide study specific informed consent
  1. * Absence of bone metastasis by bone scan or metabolic imaging (e.g. NaF PET, FACBC PET, PSMA PET, etc.) before the start of therapy.
  2. * Absence of distant lymph node metastasis by CT and/or MRI before the start of therapy.
  3. * Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
  4. * Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
  5. * Uncontrolled intercurrent illness including, but not limited to, inflammatory bowel disease, human immunodeficiency virus infection, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Contacts and Locations

Study Contact

Pretesh Patel, MD
CONTACT
404-778-3473
pretesh.patel@emory.edu

Principal Investigator

Pretesh R Patel
PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute

Study Locations (Sites)

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Pretesh R Patel, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-02-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Stage III Prostate Cancer AJCC V8
  • Stage IIIA Prostate Cancer AJCC V8
  • Stage IIIB Prostate Cancer AJCC V8
  • Stage IIIC Prostate Cancer AJCC V8