Clinical trial · Interventional
Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate
A Randomized Clinical Trial Comparing Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy Using a Combination of a Temporaory Iridium Implant Plus External Beam Radiation in Surgically Staged B2 and C Carcinoma of the Prostate
- 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)
The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.
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 |
|---|---|---|---|
| Iridium Implant | Procedure | — | UNRESOLVED |
| Standard external beam irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Iridium implant plus external beam irradiation
- interventionNames
- Procedure: Iridium Implant
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Standard external beam irradiation alone
- interventionNames
- Radiation: Standard external beam irradiation
Primary outcomes (1)
- measure
- Rate of local control as determined by biopsy at 18 months
- timeFrame
- 18-months
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must have histologically proven adenocarcinoma of the prostate * The primary tumour should be staged clinically B2 or C as classified by A.J.C. Staging System Exclusion Criteria: * Patients requiring transurethral prostatectomy (TURP) prior to diagnosis * Presence of metastases identified by bone scan, chest x-ray or CT scan of the abdomen and pelvis, or staging lymphadenectomy * Karnofsky performance status less than 80 * Inadequate laboratory results: i.e. Hb \< 12 gm/litre, WBC \< 3.5 x 10 per litre, platelets \< 100 x 10/litre, urea \> 13 mmol/litre, creatinine \> 220 mmol/litre * Unfit for surgery for other medical reasons * Age above 75 years * Failure to provide written informed consent
References
Publications (1)
- BACKGROUNDSathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154. PMID 15718316