Clinical trial · Interventional
Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer
Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
NCT00714753CI-TRIAL-00039935completedPhase 2Results 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 uses radioactive material placed directly into or near a tumor to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when given with or without external-beam radiation therapy and to see how well it works in treating patients with localized 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| hypofractionated radiation therapy | Radiation | — | UNRESOLVED |
| image-guided radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.
- interventionNames
- Radiation: brachytherapy
- Radiation: hypofractionated radiation therapy
- Radiation: image-guided radiation therapy
- Radiation: intensity-modulated radiation therapy
Primary outcomes (1)
- measure
- Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)
- timeFrame
- From baseline to 3 years after registration
- description
- Separately evaluate the tolerance of 2 radiotherapeutic regimens (HDR alone and HDR followed by hypofractionated EBRT) using the Common Terminology Criteria for Adverse Events (CTCAE v3.0). The specific adverse events (AEs) are early (i.e., within 270 days of treatment completion) grade \>3 genitourinary (GU) and/or gastrointestinal (GI) AEs, late grade 2 GU and GI AEs, and late grade ≥3 GU and GI AEs.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate, meeting one of the following criteria: * Low-risk disease (T1-T2a, Gleason score ≤ 6, and PSA \< 10 ng/mL) * Low intermediate-risk disease (T1-T2c, Gleason score ≤ 6, and PSA \< 20 ng/mL OR T1-T2a, Gleason score 7, and PSA \< 10 ng/mL) * No known nodal (N0 or NX) or distant (M0 or MX) metastases * No pubic arch interference, as defined by either of the following: * Maximum transrectal ultrasound-determined anterior-posterior (z-axis) dimension \< 4.3 cm * No more than 25% prostate volume blocked (by pubic arch) on CT scan simulation at A10°I beam's eye view * Prostate planimetry volume ≤ 60 cc as determined by step-section transrectal ultrasound * American Urological Association voiding symptom index ≤ 12 * Peak uroflow rate (Q\_max) ≥ 12 cc/second * Post-void ultrasound bladder residual volume ≤ 100 cc PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Life expectancy ≥ 5 years * WBC \> 2,000/μL * Platelet count \> 100,000/μL * PT \< 1.5 times upper limit of normal * No diabetes mellitus associated with vascular ulcers or wound-healing problems * No blood dyscrasias * No inflammatory bowel disease * No connective tissue disorder * No other prior or concurrent invasive malignancy (except nonmelanoma skin cancer) or lymphomatous or hematological malignancy (except chronic lymphocytic leukemia/lymphoma) unless patient has been continually disease-free for ≥ 5 years * No medical or psychiatric condition that would preclude giving informed consent or complying with study treatment * Able to undergo anesthesia PRIOR CONCURRENT THERAPY: * No prior transurethral resection of the prostate * No prior prostatic cryoablation or high-intensity focused ultrasound * No prior prostatectomy * No prior prostatic enucleation * No prior pelvic external beam radiotherapy * No prior radionuclide prostate brachytherapy * No prior hemi- or total hip arthroplasty * Neoadjuvant androgen suppression therapy allowed provided it was initiated 2-6 months prior to study entry and its total duration is ≤ 6 months * No concurrent anticoagulation therapy, including heparin or coumadin
References
Publications (0)
Data not yet available
No reference posted for this study.