Trial record 3 of 15 for:    proton beam and prostate

Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Cher and John Floyd Prostate Cancer Research Fund
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01950351
First received: September 23, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

The goal of this clinical research study is to learn if delivering proton therapy in higher doses per treatment may help control prostate cancer just as well as the standard of care treatment. The safety of this treatment will also be studied.

Radiation dose is measured in units called Gray (Gy). The standard of care treatment schedule for proton therapy is 1.8-2 Gy, given 1 time per day, 5 days per week over a period of 8-9 weeks.


Condition Intervention Phase
Prostate Cancer
Radiation: Proton Beam Therapy
Behavioral: Questionnaire
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Incidence of Grade 2 Gastrointestinal Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Primary endpoint is the incidence of late grade 2 or greater gastrointestinal toxicity (GI). Methods used described by Gooley et al. (1999) to estimate the cumulative incidence of late grade 2 or greater GI toxicity, considering death from any cause as a competing event, and cumulative incidence estimated at 2 years with a 95% confidence interval.


Estimated Enrollment: 150
Study Start Date: October 2013
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Beam Therapy
The total dose will be 55.5 Gy (RBE) delivered in 15 fractions of 3.7 Gy (RBE) to the prostate. Each fraction will be scheduled once daily allowing at least one day between treated fractions. Symptom questionnaire completed at baseline, during the last weeks of proton therapy, 6 months, 36 months, 48 months, and 60 months after therapy.
Radiation: Proton Beam Therapy
55.5 Gy (RBE) delivered in 15 fractions of 3.7 Gy (RBE) to the prostate. Each fraction will be scheduled once daily allowing at least one day between treated fractions.
Other Name: XRT
Behavioral: Questionnaire
Symptom questionnaire completed at baseline, during the last weeks of proton therapy, 6 months, 36 months, 48 months, and 60 months after therapy.
Other Name: Survey

Detailed Description:

Proton Therapy If you are eligible and agree to take part in this study, proton beam treatments will be delivered 2-3 days per week until you have received a total of 15 treatments.

You will receive proton beam therapy to the prostate. Your doctor will place 2-3 small tissue markers (about the size of grain of rice) into your prostate to help guide the proton therapy. Anesthesia is not needed for this procedure. For each treatment, you will lie on a treatment table for about 20-30 minutes.

Study Visits:

During proton therapy you will talk with your doctor about how you are feeling 1 time every week.

During your last week of proton therapy you will complete the questionnaire.

For the first 24 months after proton therapy every 6-12 months, blood (about 2 tablespoons) will be drawn to check your PSA levels and you will complete the questionnaire. How often these visits occur will be up to the study doctor.

At 36, 48, and 60 months after proton therapy, blood (about 2 tablespoons) will be drawn to check your PSA levels and you will be asked to complete the questionnaire.

After proton beam therapy ends, if the study doctor thinks it is needed, you will have a digital rectal exam, an MRI, a bone scan, and/or a standard prostate biopsy to check the status of the disease.

Length of Study:

You will no longer be able to take part in this study if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will end 60 months after you complete proton therapy. Your doctor will continue to provide all necessary medical care after your participation has ended.

This is an investigational study. Proton beam therapy is delivered using an FDA approved and commercially available method. The alternative schedules of proton beam therapy are investigational.

Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year of study entry. Evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson.
  2. History/physical examination with digital rectal examination of the prostate within 90 days prior to registration
  3. Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material demonstrating Gleason score 2-7 within 365 days of registration.
  4. Clinical stage T1-2b (AJCC 7th edition) and PSA <20 ng/mL within 90 days prior to registration. PSA should not be obtained within 10 days after prostate biopsy.
  5. Zubrod Performance Status 0-1 within 90 days prior to registration
  6. Age greater than or equal to 18 years
  7. Patient must be able to provide study-specific informed consent prior to study entry.
  8. Willingness and ability to complete the EPIC questionnaire

Exclusion Criteria:

  1. Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 years
  2. Evidence of distant metastases
  3. Regional lymph node involvement
  4. Previous prostatectomy, cryosurgery, or HIFU for prostate cancer
  5. Previous pelvic radiation or prostate brachytherapy
  6. Active and severe medical co-morbidity defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration, hepatic insufficiency resulting in clinical jaundice, active inflammatory bowel disease (Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or congenital coagulation defects (Patients on medical therapy with coumadin or other blood thinning agents are eligible for participation.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950351

Contacts
Contact: Thomas Pugh, MD 713-563-8961

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cher and John Floyd Prostate Cancer Research Fund
Investigators
Principal Investigator: Thomas Pugh, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01950351     History of Changes
Other Study ID Numbers: 2012-1003, NCI-2013-02347
Study First Received: September 23, 2013
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Localized prostate cancer
Adenocarcinoma of the prostate
Proton therapy
Radiation therapy
XRT
Gray
Gy
Questionnaire
Survey

Additional relevant MeSH terms:
Prostatic Neoplasms
Prostatic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 24, 2014