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Prostate Cancer Parameters for Patients Receiving Proton Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02110849
Recruitment Status : Withdrawn (Closure of IU Health Proton Facility)
First Posted : April 10, 2014
Last Update Posted : April 7, 2016
Information provided by (Responsible Party):
Indiana University

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.

Condition or disease Intervention/treatment
Prostate Cancer Radiation: Proton

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Longitudinal Study for the Evaluation of Safety and Efficacy Parameters in Prostate Cancer Patients Treated at IU Health Proton Therapy Center (IUHPTC)
Study Start Date : January 2013
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Prostate Cancer Patients
Prostate cancer patients who received proton radiation therapy
Radiation: Proton
Proton Therapy for Prostate Cancer

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]

    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Prostate cancer patients who are receiving proton radiation therapy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02110849

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United States, Indiana
Iu Health Proton Therapy Center
Bloomington, Indiana, United States, 47408
Sponsors and Collaborators
Indiana University
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Principal Investigator: Jeffery Buchsbaum, MD Indiana University Proton Therapy Center
Additional Information:

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Responsible Party: Indiana University Identifier: NCT02110849    
Other Study ID Numbers: IUHPTC-03
IRB #1206008885 ( Other Identifier: Indiana University )
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data collected
Keywords provided by Indiana University:
Proton Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases