Clinical trial · Interventional
Intensity Modulated Versus Interstitial - Radiation Therapy
A Randomized Phase II Study Comparing Intensity Modulated External Beam Radiation Therapy (IMRT) Versus Permanent Interstitial Prostate Brachytherapy (PIPB) for Low Risk and Low-tier Intermediate Risk Prostate Cancer
NCT00407875CI-TRIAL-00033754unknownN/AClinicalTrials.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)
Purpose: The purpose of this trial is to compare two different treatment options for patients with low risk and low-tier intermediate risk prostate cancer. The two treatment arms being compared in this study are: (control arm) permanent interstitial prostate brachytherapy (PIPB) VERSUS (experimental arm) intensity modulated external beam radiation therapy (IMRT). Hypothesis: The acute and late toxicities experienced by patients in the experimental arm (IMRT) are not significantly worse then the toxicities experienced by patients in the control arm (PIPB).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity Modulated External Beam Radiation Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Permanent interstitial prostate brachytherapy (PIPB)
- description
- patient will undergo permanent interstitial prostate brachytherapy (PIPB) using a transperineal approach to deliver 125Iodine Rapidstrand® seeds at the facilities of the British Columbia Cancer Agency (BCCA) by one or more of the certified prostate brachytherapists in the BCCA Prostate Brachytherapy Program. The minimum peripheral dose (MPD) to the prostate gland of the implant will be 144 Gy as per TG 43 protocol. A modified peripheral loading technique will be utilized in an effort to maintain the periurethral dose to \< 150% of the MPD. Within 48 hours of the implant, the patient will undergo a day 0 CT scan of the pelvis to assess post implant dosimetry using the standard BCCA protocol.
- interventionNames
- Procedure: Intensity Modulated External Beam Radiation Therapy
- type
- EXPERIMENTAL
- label
- Intensity modulated external beam radiation therapy (IMRT)
- description
- patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) to a volume encompassing the prostate gland. The total radiation dose will be 70 Gy delivered in 28 fractions, so that the minimum dose to the PTV is 70 Gy, with CT simulation used for planning the treatment. Prior to starting the course of IMRT, fiducial markers will be placed in the prostate to assist in localization of the prostate for planning and quality assurance during treatment.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically proven adenocarcinoma of the prostate. 2. Registration must occur within 20 weeks of biopsy. 3. History and physical examination within 8 weeks prior to randomization. 4. Patients must have either low risk or low-tier intermediate risk prostate cancer (Low risk must have all of: clinical stage \<= T2b, Gleason score \<= 6, and initial PSA \<= 10; Low-tier intermediate risk must have: clinical stage \<= T2c, \< 50% positive biopsy cores, AND EITHER Gleason score = 7 and initial PSA \<= 10 OR Gleason score \<= 6 and initial PSA \> 10 and \<= 15.) 5. Patients must have a ECG, PSA, TTT, CBC, electrolytes, Cr, INR, PTT, and random glucose within 2 weeks of registration. 6. Patients must be fit for general or spinal anesthetic. 7. Patients must have an estimated life expectancy of at least 10 years. 8. Patients must have an ECOG performance status of 0 - 2. 9. Patients must have no contraindications for high dose pelvic irradiation or transperineal interstitial brachytherapy. 10. Patients must not have received prior radiation therapy to the pelvis. 11. Patients must have no history of inflammatory bowel disease. 12. Patients must not have received prior hormonal therapy or chemotherapy. 13. Patients must not have any hormonal therapy planned as part of the therapeutic intervention. 14. Patients must have prostate volumes \< 60 cm3 on transrectal ultrasound. 15. Patients must not have received prior surgical treatment for prostate cancer including TURP, TURB, cryotherapy, laser ablation or microwave therapy. 16. Patients on coumadin therapy must be able to stop therapy safely for at least 12 days. 17. Patients must have an International Prostate Symptom Score (IPSS) of less than 20. 18. Patients must have no history of previous malignancies, except non-melanoma skin tumors. 19. Patients must have a body mass index (BMI) of \<= 32. Exclusion Criteria: Those patients who do not meet the inclusion criteria described above will be excluded from participation.
References
Publications (0)
Data not yet available
No reference posted for this study.