Clinical trial · Observational
Prostate Cancer Parameters for Patients Receiving Proton Treatment
Longitudinal Study for the Evaluation of Safety and Efficacy Parameters in Prostate Cancer Patients Treated at IU Health Proton Therapy Center (IUHPTC)
NCT02110849CI-TRIAL-00021674withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closure of IU Health Proton Facility
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prostate Cancer Patients
- description
- Prostate cancer patients who received proton radiation therapy
- interventionNames
- Radiation: Proton
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.