RECRUITING

Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

Conditions

Prostate Cancer Prostate proton radiation intermediate risk

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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 compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Official Title

Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

Quick Facts

Study Start:2012-01

Study Completion:N/A

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01492972

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
* Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA \> = 10 and \< = 20, T stage T2b - T2c * Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III). * Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. \> 6 cores are strongly recommended. * PSA values \< = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy. * ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization. * Patients must sign IRB approved study specific informed consent. * Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames. * Patients must be able to start treatment within 56 days of randomization. * Patients must be at least 18 years old. * For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination. * For brachytherapy, prostate volume must be less than 55cc prior to AS.	* Pelvic lymph nodes \> 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative. * Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery. * Previous pelvic radiation for prostate cancer. * Previous androgen suppression therapy for prostate cancer. * Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed). * Prior systemic chemotherapy for prostate cancer. * History of proximal urethral stricture requiring dilatation. * Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed). * Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study). * Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed). * History of myocardial infarction within the last 6 months.

Inclusion Criteria

Exclusion Criteria

* Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA \> = 10 and \< = 20, T stage T2b - T2c
* Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. \> 6 cores are strongly recommended.
* PSA values \< = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
* ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
* Patients must sign IRB approved study specific informed consent.
* Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
* Patients must be able to start treatment within 56 days of randomization.
* Patients must be at least 18 years old.
* For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
* For brachytherapy, prostate volume must be less than 55cc prior to AS.

* Pelvic lymph nodes \> 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
* Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
* Previous pelvic radiation for prostate cancer.
* Previous androgen suppression therapy for prostate cancer.
* Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
* Prior systemic chemotherapy for prostate cancer.
* History of proximal urethral stricture requiring dilatation.
* Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
* Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).
* Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
* History of myocardial infarction within the last 6 months.

Contacts and Locations

Principal Investigator

Carlos Vargas, MD

PRINCIPAL_INVESTIGATOR

Proton Collaborative Group

Study Locations (Sites)

Mayo Clinic

Scottsdale, Arizona, 85259-5499

United States

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, 60555

United States

Oklahoma Proton Center

Oklahoma City, Oklahoma, 73142

United States

Hampton University Proton Therapy Institute

Hampton, Virginia, 23666

United States

Collaborators and Investigators

Sponsor: Proton Collaborative Group

Carlos Vargas, MD, PRINCIPAL_INVESTIGATOR, Proton Collaborative Group

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 Date2012-01

Study Completion DateN/A

Study Record Updates

Study Start Date2012-01

Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

Prostate
proton
radiation
intermediate risk

Additional Relevant MeSH Terms

Prostate Cancer