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Clinical Studies

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  • A Phase III Trial of Radiation Therapy with or without Casodex in Patients with PSA Elevation Following Radical Prostatectomy for pT3N0 Carcinoma of the Prostate Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II, stage III, or recurrent prostate cancer and elevated PSA levels following radical prostatectomy.

  • 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 (PARTIQoL) Rochester, Minn.

    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.

  • Proton-Based Stereotactic Ablative Body Radiotherapy (SABR) for Select Patients With Clinically Localized Prostate Cancer (ROR1752) Rochester, Minn.

    Stereotactic ablative body radiotherapy (SABR), or stereotactic body radiotherapy (SBRT), is a specialized form of radiotherapy used to treat prostate cancer with five treatments over two weeks, compared with a conventional eight-week or longer treatment course. The purpose of this trial is to investigate the effect that proton-based SABR has on quality-of-life in patients with localized prostate cancer. The evaluation and treatment will otherwise follow standard of care, and is not considered investigational.

    Patients undergo evaluation and medical care in the same way that they would if they were not part of this trial. This may include standard of care blood tests (for example, PSA) and scans (for example, MRI). Five SABR treatments will be given with proton beam therapy over two weeks, with up to two treatments each week. Participants will complete a quality-of life questionnaire before starting SABR, at the end of SABR, at three, six and 12 months after SABR, and then yearly.