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

Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:July 2012
End Date:December 2026

Use our guide to learn which trials are right for you!

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)
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

After your radiation therapy you will have follow up visits at 3,6,9,12,18,24,36,48 and 60

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

- 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
We found this trial at
Cleveland, Ohio 44106
Phone: 216-286-3903
Cleveland, OH
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
Principal Investigator: Jason A. Efstathiou, MD,DPhil
Phone: 617-726-5866
Boston, MA
Click here to add this to my saved trials
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Justin E. Bekelman, M.D.
Phone: 215-662-7266
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
Philadelphia, PA
Click here to add this to my saved trials
Chicago, Illinois 60190
Phone: 630-821-6400
Chicago, IL
Click here to add this to my saved trials
College Park, Maryland 20742
Phone: 410-328-6080
College Park, MD
Click here to add this to my saved trials
Danvers, Massachusetts 01923
Principal Investigator: Derek Chism, MD
Phone: 978-882-6060
Danvers, MA
Click here to add this to my saved trials
Jacksonville, Florida 32206
Phone: 904-588-1475
Jacksonville, FL
Click here to add this to my saved trials
Knoxville, Tennessee 37909
Phone: 865-862-1600
Knoxville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey 08903
Phone: 732-253-3939
New Brunswick, NJ
Click here to add this to my saved trials
Rochester, Minnesota 55905
Phone: 507-284-2511
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 314-362-8566
Saint Louis, MO
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Phone: 206-598-4100
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
Seattle, WA
Click here to add this to my saved trials
Somerset, New Jersey 08873
Phone: 609-655-5755
Somerset, NJ
Click here to add this to my saved trials