Prostate Cancer Parameters for Patients Receiving Proton Treatment



Status:Withdrawn
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2013
End Date:April 2016

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Longitudinal Study for the Evaluation of Safety and Efficacy Parameters in Prostate Cancer Patients Treated at IU Health Proton Therapy Center (IUHPTC)

To prospectively collect data from patients treated with proton therapy for prostate cancer
using the IUHPTC technique for the evaluation of toxicity and efficacy of this treatment
technique.

The major purpose of this study is to analyze side effects experienced and self-reported by
prostate cancer patients undergoing proton radiation therapy at IUHPTC. With the information
collected, the investigators will establish pre-existing conditions before proton treatment
and measure side effects after treatments that are not related to the pre-existing
conditions. Also, to compare long-term side effects for patients who are treated with
hormone suppression therapy along with their proton therapy to those patients who do not get
treated with hormone suppression therapy. This information will help doctors better
understand the side effects experienced and may help provide valuable information for future
patients making decisions regarding their treatment options.

Finally, to develop a database of information regarding the treatment and outcomes for
patients with prostate cancer in order to improve care of patients with this type of cancer.

Inclusion Criteria:

- Subjects must have histologically or cytologically confirmed adenocarcinoma of the
prostate and are scheduled to receive proton radiation treatment at IUHPTC.

- Subjects with any stage or grade of tumor will be allowed including proton salvage
therapy in the context of a rising PSA after surgery and a negative metastatic
work-up.

- Prior use of Lupron therapy or a similar agent is allowed. Use of Lupron or similar
agent must be for ≤ 6 months prior to enrollment.

- Use of Casodex and agents in the same drug class is allowed. Age is ≥ 18 years at the
time of consent.

- The ability to understand and willingness to sign an informed consent and
authorization for the release of health information.

Exclusion Criteria:

-Evidence of distant metastases at the time of enrollment.
We found this trial at
1
site
Bloomington, Indiana 47408
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from
Bloomington, IN
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