Protocol Summary

Protocol No.: OCR16036

Sponsor Protocol No.: PARTIQoL

Study Title
PARTIQoL: Prostate Advanced Radiation Technologies Investigating Quality of Life: A Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer.

Principal Investigator(s)
Mendenhall, Nancy

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.

Phase: Phase III (Cancer Control)

Age Group: Adult

Scope: National

Proton Beam Therapy:
5 days per week up to 9 weeks

Intensity Modulated Radiation Therapy:
5 times per week up to 9 weeks

Detailed Eligibility
1. Ages 18 years old and older
2. Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
3. Clinical stages T1c to T2c
4. PSA 5. 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 =6. Gleason score=7. ECOG Performance Status 0-1 as documented within 3 months prior to study entry
8. 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

1. Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
2. Prior or planned androgen deprivation or bilateral orchiectomy
3. Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry
4. Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus
5. 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.
6. Individuals who have AIDS (CD4 7. Major medical or psychiatric illness
8. 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

Applicable Disease Sites
Prostate Cancer

Participating Institutions
UF Jacksonville : Audrey Gardner

Audrey Gardner