RECRUITING

Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

Conditions

Prostate Cancer Proton Radiation, Prostate Cancer

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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

The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.

Official Title

Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Quick Facts

Study Start:2009-08

Study Completion:2050-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT00969111

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 Criteria	Exclusion Criteria
* Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy. * Maximum PSA value of 20 ng/ml.	* Evidence of distant metastasis (M1). * Prior systemic chemotherapy for any reason. * Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment. * Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed). * History of hip replacement. * Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years. * Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Inclusion Criteria

Exclusion Criteria

* Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
* Maximum PSA value of 20 ng/ml.

* Evidence of distant metastasis (M1).
* Prior systemic chemotherapy for any reason.
* Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
* Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
* History of hip replacement.
* Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
* Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Contacts and Locations

Principal Investigator

Randal H Henderson, MD

PRINCIPAL_INVESTIGATOR

University of Florida Proton Therapy Institute

Study Locations (Sites)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206

United States

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, 60555

United States

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Proton Collaborative Group

Randal H Henderson, MD, PRINCIPAL_INVESTIGATOR, University of Florida Proton Therapy 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 Date2009-08

Study Completion Date2050-08

Study Record Updates

Study Start Date2009-08

Study Completion Date2050-08

Terms related to this study

Keywords Provided by Researchers

Proton Radiation, Prostate Cancer

Additional Relevant MeSH Terms

Prostate Cancer