Prostate Cancer Parameters for Patients Receiving Proton Treatment

NCT ID: NCT02110849

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Prostate Cancer Patients

Prostate cancer patients who received proton radiation therapy

Proton

Intervention Type: RADIATION

Proton Therapy for Prostate Cancer

Interventions

Proton

Proton Therapy for Prostate Cancer

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffery Buchsbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Proton Therapy Center

Locations

Iu Health Proton Therapy Center

Bloomington, Indiana, United States

Countries

United States

Other Identifiers

IRB #1206008885

Identifier Type: OTHER

Identifier Source: secondary_id

IUHPTC-03

Identifier Type: -

Identifier Source: org_study_id