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Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Low-Intermediate Risk Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Low-Intermediate Risk Prostate Cancer

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

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 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of PBT vs. IMRT

Outcome Description:

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)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jason A Efstathiou, MD, DPhil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Dana-Farber Cancer Institute IRB

Study ID:




Start Date:

July 2012

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Low Risk
  • Low Intermediate Risk
  • Prostatic Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104