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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 6, 2014
Last verified: October 2014

June 8, 2012
October 6, 2014
July 2012
January 2016   (final data collection date for primary outcome measure)
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)
Efficacy of PBT vs. IMRT [ Time Frame: 6 months ] [ 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 6 months following radiation (where higher scores represent better outcomes)
Complete list of historical versions of study NCT01617161 on ClinicalTrials.gov Archive Site
  • 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 late effects such as second cancers
  • 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
  • Representativeness/Generalizability of Trial Findings [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Explore the use of participant registry to assess the representativeness and generalizability of the randomized trial findings to a broader spectrum of eligible patients and provide pilot information for a subsequent larger multicenter registry
  • 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
Not Provided
Not Provided
 
Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Radiation: Proton Beam Therapy
    5 days per week 8-9 weeks
  • Radiation: Intensity Modulated Radiation Therapy
    5 times per week 8-9 weeks
  • Active Comparator: PBT
    Proton Beam Therapy
    Intervention: Radiation: Proton Beam Therapy
  • Active Comparator: IMRT
    Intensity Modulated Radiation Therapy
    Intervention: Radiation: Intensity Modulated Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
January 2016   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
United States
 
NCT01617161
11-497
Yes
Jason Efstathiou, Massachusetts General Hospital
Massachusetts General Hospital
  • University of Pennsylvania
  • National Cancer Institute (NCI)
Principal Investigator: Jason A Efstathiou, MD, DPhil Massachusetts General Hospital
Principal Investigator: Justin E Bekelman, MD University of Pennsylvania
Massachusetts General Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP