Proton Therapy vs. IMRT for Low or Low-Intermediate Risk Prostate Cancer
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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: | Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Low-Intermediate Risk Prostate Cancer |
- 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)
- 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: | 461 |
| 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 |
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 including digital rectal examination of prostate within 30 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, 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
- 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| 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 Efstathiou, MD | |
| 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. | |
| 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: | January 4, 2013 |
| Health Authority: | United States: Dana-Farber Cancer Institute IRB |
Keywords provided by Massachusetts General Hospital:
|
Low Risk Low 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 May 19, 2013