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

Prostate Cancer Clinical Trial

— PARTIQoL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01617161
• Other study ID #: 11-497
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 25, 2012
• Est. completion date: August 2027

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 454
• Est. completion date: August 2027
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 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

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

• 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.

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Proton Beam Therapy
5 days per week up to 9 weeks
• Intensity Modulated Radiation Therapy
5 times per week up to 9 weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern Medicine Chicago Proton Center	Chicago	Illinois
United States	University Hospital of Cleveland	Cleveland	Ohio
United States	University of Maryland Medical Center	College Park	Maryland
United States	Mass General/North Shore Cancer Center	Danvers	Massachusetts
United States	University of Florida Health Proton Therapy Institute	Jacksonville	Florida
United States	Provision Proton Therapy Center	Knoxville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	University of Washington Medical Center	Seattle	Washington
United States	Princeton ProCure Proton Therapy Center	Somerset	New Jersey

Sponsors (13)

Lead Sponsor

Collaborator

Massachusetts General Hospital

Mayo Clinic, National Cancer Institute (NCI), Northwestern Medicine Chicago Proton Center, ProCure Proton Therapy Center, Provision Center for Proton Therapy, Rutgers Cancer Institute of New Jersey, University Hospitals Cleveland Medical Center, University of Florida Proton Therapy Institute, University of Maryland Medical Center, University of Pennsylvania, University of Washington, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	Identification and Evaluation Biomarkers of PCa Behavior	Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy	2 years
Secondary	Long Term Survival	Assess longer-term rates of disease-specific and overall survival as well as development of late effects such as second cancers	10 years