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Clinical Trials (PDQ®)

Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, TreatmentActive18 and overNCI, Other11-497
NCT01617161

Trial Description

Summary

We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams.

IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects.

In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.

Further Study Information

Because no one knows which of the study options is best, you will be "randomized" into one of the study groups: IMRT or PBT. Randomization means that you are put into a group by chance, like flipping a coin. Neither you nor the research doctor will choose which group you will be in. You will have an equal chance of being placed in either group. Randomization makes the study better from a scientific point of view because it helps ensure that patients receiving IMRT and proton therapy are similar. You will be receiving only one type of radiation, either IMRT or PBT throughout your participation in the study.

Before you begin radiation therapy you will have a pelvic CT scan in order to design your radiation treatment. Doctors will use information gathered from these scans to plan the best way to deliver radiation to your tumor.

Both types of radiation therapy will be given once a day for 5 days (no weekends or holidays) over the course of 8-9 weeks. Both IMRT and PBT will require that you lie on a table for less than 15 minutes to obtain your treatment.

During each visit you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you might be taking. You will also undergo a physical exam and complete some quality of life questionnaires.

After your radiation therapy you will have follow up visits at 3,6,9,12,18,24,36,48 and 60 months.

Eligibility Criteria

Inclusion Criteria:

  • Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
  • Clinical stages T1c to T2b
  • PSA <20
  • Gleason score ≤6 if PSA <20 or Gleason score 3 + 4 = 7 or 4 + 3 = 7 if PSA <20
  • Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry
  • Participants who are currently receiving Dutasteride (or have received it within the last 90 days) or Finasteride (or have received it within the last 30 days) must have a PSA of ≤ 10

Exclusion Criteria:

  • Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
  • Prior or planned androgen deprivation or bilateral orchiectomy
  • Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry
  • Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus
  • History of other malignancies within the past 5 years
  • Individuals who have AIDS (CD4 < 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible.
  • Major medical or psychiatric illness

Trial Contact Information

Trial Lead Organizations/Sponsors

Massachusetts General Hospital

Abramson Cancer Center of the University of Pennsylvania

National Cancer Institute

Jason A Efstathiou, MD, DPhilPrincipal Investigator

Justin E Bekelman, MDPrincipal Investigator

Trial Sites

U.S.A.
Massachusetts
  Boston
 Massachusetts General Hospital
 Jason A Efstathiou, MD, DPhil Ph: 617-726-5866
  Email: jefstathiou@partners.org
 Jason A. Efstathiou, MD,DPhilPrincipal Investigator
Pennsylvania
  Philadelphia
 Hospital of the University of Pennsylvania
 Justin E. Bekelman, M.D. Ph: 215-662-7266
  Email: Bekelman@uphs.upenn.edu
 Justin E. Bekelman, M.D.Principal Investigator

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01617161
ClinicalTrials.gov processed this data on October 08, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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