Clinical trial · Observational
Changes in DNA After Radiation Therapy in Patients With Prostate Cancer
Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study
NCT00899912CI-TRIAL-00019798completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA after radiation therapy and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at changes in DNA after radiation therapy in patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis
- timeFrame
- Specimens collected at the time of brachytherapy
Secondary outcomes (3)
- measure
- Comparison of gene expression patterns between frozen and paraffin-embedded tissue in patients treated on the brachytherapy alone arm of protocol RTOG-0232
- timeFrame
- After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
- measure
- Comparison of genes to determine which are expressed differentially before and after radiotherapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232
- timeFrame
- After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
- measure
- Gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, locally confined adenocarcinoma of the prostate * Zubrod performance 0-1 * Clinical stages T1c - T2b, N0, M0 * Combined Gleason score 7 if prostate specific antigen (PSA) \< 10, combined Gleason score \< 7 if PSA 10 - 20; PSA must be ≤ 20 ng/mL, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (TRUS) ≤ 60 cc. * American Urological Association (AUA) score ≤ 15 (alpha blockers are allowed). * Age ≥ 18 years old and must sign a study-specific informed consent form Exclusion Criteria: * No clinically or pathologically involved lymph nodes * No distant metastases or significant obstructive symptoms * No prior chemotherapy, pelvic radiation, transurethral prostatectomy (TURP), cryosurgery, TUNA, transurethral microwave thermotherapy (TUMT) or radical surgery for carcinoma of the prostate is allowed. * No previous hormonal therapy beginning \< 2 months or \> 6 months prior to registration is allowed. * No previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years. * No hip prosthesis or major medical or psychiatric illnesses are allowed. prior to study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.