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Prostate Cancer Parameters for Patients Receiving Proton Treatment

This study has been withdrawn prior to enrollment.
(Closure of IU Health Proton Facility)
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT02110849
First received: April 3, 2014
Last updated: April 6, 2016
Last verified: April 2016
  Purpose
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 Intervention
Prostate Cancer Radiation: Proton

Study Type: Observational [Patient Registry]
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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.



Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prostate Cancer Patients
Prostate cancer patients who received proton radiation therapy
Radiation: Proton
Proton Therapy for Prostate Cancer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02110849

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

Additional Information:
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT02110849     History of Changes
Other Study ID Numbers: IUHPTC-03
IRB #1206008885 ( Other Identifier: Indiana University )
Study First Received: April 3, 2014
Last Updated: April 6, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data collected

Keywords provided by Indiana University:
Prostate
Proton Therapy
Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 23, 2017