Clinical trial · Interventional
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
NCT00091390CI-TRIAL-00046506completedPhase 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: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III 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 |
|---|---|---|---|
| External beam radiotherapy | Radiation | — | UNRESOLVED |
| High Dose brachytherapy boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- External Beam Radiotherapy and High Dose brachytherapy boost
- interventionNames
- Radiation: High Dose brachytherapy boost
- Radiation: External beam radiotherapy
Primary outcomes (1)
- measure
- Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months
- timeFrame
- From 9 to 18 months after start of study treatment
- description
- Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. "Late" is defined as occurring after 9 months from the start of study treatment. Because of the lead time of 9 months, the percentage at 18-months was estimated by the 9-month rate using the cumulative incidence method starting at the 10th month. Death was treated as a competing risk.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0. 2. Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)). 3. The patient will be clinically M0. 4. Zubrod status 0-1. 5. No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable. 6. One of the following combinations of factors: Clinical stage T1c-T2c, Gleason score 2-6 and prostate-specific antigen (PSA) \>10 but ≤ 20 Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20 Clinical stage T1c-T3b, Gleason score 7-10 and PSA ≤ 20 7. Patients must sign a study-specific consent form prior to registration. Exclusion Criteria: 1. Stage T4 disease. 2. Lymph node involvement (N1). 3. Evidence of distant metastases (M1). 4. Radical surgery for carcinoma of the prostate. 5. Previous hormonal therapy beginning \> 120 days prior to registration. 6. Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. 7. Prior transurethral resection of the prostate (TURP). 8. Prior invasive malignancy(except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the oral cavity or bladder are permissible). 9. Hip prosthesis.
References
Publications (3)
- RESULTHsu IC, Bae K, Shinohara K, Pouliot J, Purdy J, Ibbott G, Speight J, Vigneault E, Ivker R, Sandler H. Phase II trial of combined high-dose-rate brachytherapy and external beam radiotherapy for adenocarcinoma of the prostate: preliminary results of RTOG 0321. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):751-8. doi: 10.1016/j.ijrobp.2009.08.048. Epub 2010 Mar 6. PMID 20207506
- RESULTJacob D, Raben A, Sarkar A, Grimm J, Simpson L. Anatomy-based inverse planning simulated annealing optimization in high-dose-rate prostate brachytherapy: significant dosimetric advantage over other optimization techniques. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):820-7. doi: 10.1016/j.ijrobp.2008.02.009. Epub 2008 May 1. PMID 18455325
- DERIVEDHsu IC, Rodgers JP, Shinohara K, Purdy J, Michalski J, Roach M 3rd, Vigneault E, Ivker RA, Pryzant RM, Kuettel M, Taussky D, Gustafson GS, Raben A, Sandler HM. Long-Term Results of NRG Oncology/RTOG 0321: A Phase II Trial of Combined High Dose Rate Brachytherapy and External Beam Radiation Therapy for Adenocarcinoma of the Prostate. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):700-707. doi: 10.1016/j.ijrobp.2020.11.008. Epub 2020 Nov 10. PMID 33186617