Active — Not RecruitingNot Applicable

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

United States454 participantsStarted 2012-07-25

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 hav…

What they're measuring

Efficacy of PBT vs. IMRT

Timeframe: 2 years

Trial details

NCT IDNCT01617161

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12