Prostate Cancer Parameters for Patients Receiving Proton Treatment

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02110849
• Other study ID #: IUHPTC-03
• Secondary ID: IRB #1206008885
• Status: Withdrawn
• Phase: N/A
• First received: April 3, 2014
• Last updated: April 6, 2016
• Start date: January 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indiana University: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Proton
Proton Therapy for Prostate Cancer

Locations

Country	Name	City	State
United States	Iu Health Proton Therapy Center	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To prospectively collect a composite of toxicity events on patients who treated with proton therapy for prostate cancer using the IUHPTC technique for the evaluation of toxicity and efficacy of this treatment technique.	A collection of toxicity events of proton therapy, evaluate the long-term side effects of hormone suppression vs. non-hormone suppression and documents the clinical benefits this therapy in regards to urinary, sexual and gastrointestinal issues.; To do this the investigators will use the following standard of care data collection forms that include; the International Index of Erectile Function (Attachment 1), the American Urological Association Symptom Index (Attachment 2) and the Radiation Therapy Initial Nursing Assessment (Attachment 3), The prostate preexisting conditions review (attachment 4) and the prostate side effects review (attachment 5). Other clinical data such us demographics, vitals, previous treatments, PSA(prostate specific antigen/Hormone results, follow up data, as described in the protocol schedule of events, will be collected as per routine standard of care.	12 months	Yes

External Links

•   IU Health Proton Therapy Center