Clinical trial · Observational
Study of Quality of Life for Prostate Proton Therapy
Prospective Evaluation of Quality of Life After Proton Therapy for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this research study is to collect information on the side effects of proton radiation therapy given for the treatment of prostate cancer as well as the effect of proton therapy on quality of life. Information on your treatment and how you react to the treatment will be collected. Researchers will use this information to try to understand how people tolerate proton radiation therapy for prostate cancer.
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 |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma.
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- To collect information on the side effects of proton radiation therapy given for the treatment of prostate cancer as well as the effect of proton therapy on quality of life.
- timeFrame
- 4 Years
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma with Gleason scoring. 2. 1992 AJCC clinical stage T1-T3c on digital rectal exam. 3. PSA within 4 weeks of study entry. 4. Zubrod performance status of 0-1 with a life expectancy of at least 10 years. 5. Prior hormonal therapy allowed if began no more than three months prior to registration. 6. Patient must be able to adhere to follow-up schedule either personally or via mail or phone. 7. Patient must be able to speak, read and understand English. 8. Patient must give informed consent. Exclusion Criteria: 1. Histology other than adenocarcinoma. 2. Evidence of distant or nodal metastasis. 3. Prior pelvic radiotherapy or chemotherapy. 4. Prior or planned radical prostate surgery. 5. Prior local therapy for prostate cancer. 6. Previous and/or concurrent malignancy unless disease free for \>5 years. Basal cell and non-invasive squamous cell carcinoma of the skin will not exclude patient from eligibility. 7. History of inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis). 8. Patients with metallic devices in the hip/pelvis (e.g. hip prostheses) that may interfere with proton dosimetry will not be eligible.
References
Publications (0)
Data not yet available