Prostate CancerPARTIQoLNCT01617161
Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer
A study testing Proton Beam Therapy and Intensity Modulated Radiation Therapy in people with Prostate Cancer, run by Massachusetts General Hospital at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Proton Beam Therapy and Intensity Modulated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 13 sitesUnited States
- Study dates
- 25 Jul 2012to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
- Clinical stages T1c to T2c
- PSA <20, within 6 months 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
- Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7
- ECOG Performance Status 0-1 as documented within 3 months prior to study entry
- 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
Who cannot join
- 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
- Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval.
- Individuals who have AIDS (CD4 < 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible.
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- Major medical or psychiatric illness
- Individuals with any of the following conditions are excluded from this study:
- 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
- History of Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects within the last 12 months
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern Medicine Chicago Proton Center
Chicago, Illinois, 60190
University Hospital of Cleveland
Cleveland, Ohio, 44106
University of Maryland Medical Center
College Park, Maryland, 20742
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32206
Provision Proton Therapy Center
Knoxville, Tennessee, 37909
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington Medical Center
Seattle, Washington, 98195
Princeton ProCure Proton Therapy Center
Somerset, New Jersey, 08873
Washington University
St Louis, Missouri, 63110
About this study
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
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.
Read the 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) for up to 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.
- Conditions
- Prostate Cancer
- Being tested
- Proton Beam Therapy, Intensity Modulated Radiation Therapy
- Keywords
- Low Risk, Intermediate Risk
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam TherapyRadiation
5 days per week up to 9 weeks
Intensity Modulated Radiation TherapyRadiation
5 times per week up to 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| PBT | Active comparator | Proton Beam Therapy Receives: Radiation: Proton Beam Therapy |
| IMRT | Active comparator | Intensity Modulated Radiation Therapy Receives: Radiation: Intensity Modulated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PBT vs. IMRT
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)
Measured: 2 years
Secondary outcomes (5)
Disease Specific Quality of Life
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
Measured: 2 years
Cost Effectiveness of PBT vs. IMRT
Assess the cost-effectiveness of PBT versus IMRT under current conditions and model future cost-effectiveness for alternative treatment delivery and cost scenarios
Measured: 2 years
Radiation Dose and Bowel, Urinary and Erectile Function
Develop predictive models to examine the associations between selected metrics of individual radiation dose distributions and patient reported bowel, urinary and erectile function
Measured: 2 years
Identification and Evaluation Biomarkers of PCa Behavior
Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy
Measured: 2 years
Long Term Survival
Assess longer-term rates of disease-specific and overall survival as well as development of late effects such as second cancers
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study start25 Jul 2012
- Primary completionDec 2025
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, National Cancer Institute (NCI), Northwestern Medicine Chicago Proton Center, ProCure Proton Therapy Center, Washington University School of Medicine, University of Washington, Rutgers Cancer Institute of New Jersey, Mayo Clinic, University of Maryland, Baltimore, University Hospitals Cleveland Medical Center, University of Florida, Provision Center for Proton Therapy
- Responsible party
- Principal investigator, Jason Efstathiou, Massachusetts General Hospital
- Investigators
- Jason A Efstathiou, MD, DPhil, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617161
- Sponsor's protocol ID
- 11-497
- Acronym
- PARTIQoL
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2012
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu Y, Patel SA, Jani AB, Gillespie TW, Patel PR, Godette KD, Hershatter BW, Shelton JW, McDonald MW. Overall Survival After Treatment of Localized Prostate Cancer With Proton Beam Therapy, External-Beam Photon Therapy, or Brachytherapy. Clin Genitourin Cancer. 2021 Jun;19(3):255-266.e7. doi: 10.1016/j.clgc.2020.08.009. Epub 2020 Aug 28.
PubMed 32972877
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01617161
- Acronym / sponsor ID
- PARTIQoL / 11-497
- Conditions
- Prostate Cancer
- Keywords
- Low Risk, Intermediate Risk
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Pennsylvania, National Cancer Institute (NCI), Northwestern Medicine Chicago Proton Center, ProCure Proton Therapy Center, Washington University School of Medicine, University of Washington, Rutgers Cancer Institute of New Jersey, Mayo Clinic, University of Maryland, Baltimore, University Hospitals Cleveland Medical Center, University of Florida, Provision Center for Proton Therapy
- Study start
- 25 Jul 2012 (actual)
- Primary completion
- Dec 2025 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) for up to 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBT | Active comparator | Radiation: Proton Beam TherapyProton Beam Therapy |
| IMRT | Active comparator | Radiation: Intensity Modulated Radiation TherapyIntensity Modulated Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
- Clinical stages T1c to T2c
- PSA <20, within 6 months 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
- Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7
Key exclusion criteria (13 listed)
- 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
- Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Beam Therapy5 days per week up to 9 weeks | Radiation | PBT |
| Intensity Modulated Radiation Therapy5 times per week up to 9 weeks | Radiation | IMRT |
Primary outcome
Efficacy of PBT vs. IMRT
Time frame: 2 years
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)
5 secondary outcomes
Disease Specific Quality of Life
Time frame: 2 years
Cost Effectiveness of PBT vs. IMRT
Time frame: 2 years
Radiation Dose and Bowel, Urinary and Erectile Function
Time frame: 2 years
Identification and Evaluation Biomarkers of PCa Behavior
Time frame: 2 years
Long Term Survival
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Derived from this study: PubMed 32972877Liu Y, Patel SA, Jani AB, Gillespie TW, Patel PR, Godette KD, Hershatter BW, Shelton JW, McDonald MW. Overall Survival After Treatment of Localized Prostate Cancer With Proton Beam Therapy, External-Beam Photon Therapy, or Brachytherapy. Clin Genitourin Cancer. 2021 Jun;19(3):255-266.e7. doi: 10.1016/j.clgc.2020.08.009. Epub 2020 Aug 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason A Efstathiou, MD, DPhil principal investigator
Massachusetts General Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Beam Therapy and Intensity Modulated Radiation Therapy in people with Prostate Cancer, run by Massachusetts General Hospital at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of PBT vs. IMRT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01617161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.