Clinical trial · Interventional
Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma
- 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: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have 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 (100/110) | Radiation | — | UNRESOLVED |
| Brachytherapy (125/145) | Radiation | — | UNRESOLVED |
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EBRT + Brachytherapy
- description
- External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
- interventionNames
- Radiation: Brachytherapy (100/110)
- Radiation: External Beam Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Brachytherapy Only
- description
- Transperineal interstitial permanent brachytherapy (125/145)
- interventionNames
- Radiation: Brachytherapy (125/145)
Primary outcomes (1)
- measure
- 5-Year Freedom From Progression Rate
- timeFrame
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 * T1c-T2b, N0, M0 * Intermediate-risk disease, as defined by 1 of the following: * Gleason score \< 7 AND prostate-specific antigen (PSA) 10-20 ng/mL * Gleason score 7 AND PSA \< 10 ng/mL * No evidence of distant metastases * Prostate volume ≤ 60 cc by transrectal ultrasonography * American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Patients must use effective contraception * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site * No major medical or psychiatric illness that would preclude study therapy * No hip prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Prior neoadjuvant hormonal therapy allowed provided the following are true: * Therapy was initiated within 2-6 months of study enrollment * Therapy was no more than 6 months in duration * Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration * No concurrent hormonal therapy Radiotherapy * No prior pelvic radiotherapy Surgery * No prior radical surgery for prostate cancer * No prior transurethral resection of the prostate * No prior cryosurgery Other * No prior transurethral needle ablation of the prostate * No prior transurethral microwave thermotherapy of the prostate
References
Publications (1)
- DERIVEDMichalski JM, Winter KA, Prestidge BR, Sanda MG, Amin M, Bice WS, Gay HA, Ibbott GS, Crook JM, Catton CN, Raben A, Bosch W, Beyer DC, Frank SJ, Papagikos MA, Rosenthal SA, Barthold HJ, Roach M 3rd, Moughan J, Sandler HM. Effect of Brachytherapy With External Beam Radiation Therapy Versus Brachytherapy Alone for Intermediate-Risk Prostate Cancer: NRG Oncology RTOG 0232 Randomized Clinical Trial. J Clin Oncol. 2023 Aug 20;41(24):4035-4044. doi: 10.1200/JCO.22.01856. Epub 2023 Jun 14. PMID 37315297