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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
University of Pennsylvania
Information provided by (Responsible Party):
Jason Efstathiou, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01617161
First received: June 8, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Proton Beam Therapy
Radiation: Intensity Modulated Radiation Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prostate Advanced Radiation Technologies Investigating Quality of Life (PARTIQoL): A Phase III Randomized Clinical Trial of Proton Therapy vs IMRT for Low or Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Efficacy of PBT vs. IMRT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Compare the reduction in mean EPIC bowel scores for men with low or low-intermediate risk PCa treated with PBT versus IMRT at 24 months following radiation (where higher scores represent better outcomes)


Secondary Outcome Measures:
  • Disease Specific Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assess the effectiveness of PBT versus IMRT for men with low or low-intermediate risk PCa in terms of disease-specific quality of life as measured by patient-reported outcomes, perceptions of care and adverse events

  • Cost Effectiveness of PBT vs. IMRT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assess the cost-effectiveness of PBT versus IMRT under current conditions and model future cost-effectiveness for alternative treatment delivery and cost scenarios

  • Radiation Dose and Bowel, Urinary and Erectile Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Develop predictive models to examine the associations between selected metrics of individual radiation dose distributions and patient reported bowel, urinary and erectile function

  • Identification and Evaluation Biomarkers of PCa Behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy

  • Long Term Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Assess longer-term rates of disease-specific and overall survival as well as development of laste effects such as second cancers


Estimated Enrollment: 400
Study Start Date: July 2012
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PBT
Proton Beam Therapy
Radiation: Proton Beam Therapy
5 days per week 8-9 weeks
Active Comparator: IMRT
Intensity Modulated Radiation Therapy
Radiation: Intensity Modulated Radiation Therapy
5 times per week 8-9 weeks

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • 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
  • May have received finasteride as long as it was discontinued at least 30 days prior to study entry
  • May have received dutasteride as long as it was discontinued at least 90 days prior to study entry

Exclusion Criteria:

  • Prior surgery (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
  • History of HIV positivity
  • Major medical or psychiatric illness
  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: NCT01617161

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jason A Efstathiou, MD, DPhil    617-726-5866    jefstathiou@partners.org   
Principal Investigator: Jason A. Efstathiou, MD,DPhil         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Justin E. Bekelman, M.D.    215-662-7266    Bekelman@uphs.upenn.edu   
Principal Investigator: Justin E. Bekelman, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
University of Pennsylvania
Investigators
Principal Investigator: Jason A Efstathiou, MD, DPhil Massachusetts General Hospital
Principal Investigator: Justin E Bekelman, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Jason Efstathiou, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01617161     History of Changes
Other Study ID Numbers: 11-497
Study First Received: June 8, 2012
Last Updated: April 11, 2014
Health Authority: United States: Dana-Farber Cancer Institute IRB

Keywords provided by Massachusetts General Hospital:
Low Risk
Intermediate Risk

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014