Clinical trial · Interventional
Internal Radiation Therapy in Treating Patients With Prostate Cancer
A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
NCT00573833CI-TRIAL-00030000completedN/AResults postedClinicalTrials.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: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HDR Brachytherapy
- description
- 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
- interventionNames
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- Radiation: brachytherapy
Primary outcomes (2)
- measure
- Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
- timeFrame
- At scheduled 3 month intervals for one year
- description
- Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as \> or = grade 3 NCI CTC toxicity
- measure
- Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria: * PSA 10-20 ng/mL * Gleason score ≥ 7 * Stage ≥ T2b AND \< T3 * Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT) * Prostate size \< 60 cc by MRI or CT imaging * International Prostate Symptom Score Index ≤ 15 Exclusion criteria: * Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination) * Suspected extracapsular disease will not be considered an exclusion criteria * PSA \> 20 ng/mL * Presence of distant metastases PATIENT CHARACTERISTICS: * WBC ≥ 3,500/mm³ * Platelet count ≥ 75,000/mm³ * Hemoglobin ≥ 10 g/dL * Creatinine ≤ 1.5 mg/dL * Liver function tests ≤ 1.5 times normal * INR ≤ 2.5 * Able to complete quality of life questionnaires * Able to give informed consent * No active perineal infections * No history of urethral stricture * No prior history of pelvic malignancy * No prior history of lymphoma disease, ulcerative colitis, or anal fissures * No contraindications to general anesthesia * No pacemaker PRIOR CONCURRENT THERAPY: * No prior transurethral resection of the prostate * No prior pelvic radiotherapy * No prior treatment for prostate cancer except for hormone therapy
References
Publications (0)
Data not yet available
No reference posted for this study.