Prostate Cancer Parameters for Patients Receiving Proton Treatment

Indiana University

Status

Withdrawn

Conditions

Prostate Cancer

Treatments

Radiation: Proton

Study type

Observational

Funder types

Other

Identifiers

NCT02110849

IUHPTC-03

IRB #1206008885 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.