Clinical trial · Interventional
Partial Prostate Salvage High Dose Rate Brachytherapy
High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy
- 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)
A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.
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 |
|---|---|---|---|
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDR partial prostate brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HDR partial prostate brachytherapy
- description
- 2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI
- interventionNames
- Radiation: HDR partial prostate brachytherapy
Primary outcomes (1)
- measure
- Late adverse gastrointestinal or genitourinary events grade 3 or higher
- timeFrame
- 3-60 months
- description
- Common Terminology Criteria for Adverse Events (CTCAE V4.0)
Secondary outcomes (7)
- measure
- Late Quality of Life
- timeFrame
- 3-60 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>45 and Life expectancy \>10 years * Previous External Beam Radiotherapy (EBRT) or LDR brachytherapy w * \> 3 year interval since EBRT or LDR Brachytherapy * No late toxicity from prior EBRT ≥ grade 2 * PSA \> nadir + 2 ng/ml and \< 10 ng/ml * PSA Doubling time \> 6 months * Radiographic evidence corresponding with site of recurrence in an under-dosed or untreated site. The recurrence should correspond to the site of original disease or be located in the seminal vesical +/- adjacent prostate as only area of recurrence (i.e. unifocal recurrence). * Per Investigator, recurrence is suitable for implant with HDR brachytherapy and patient is suitable for procedure under anesthesia, spinal or general. * Negative staging of the abdomen/pelvis and bones. * Willing to provide informed consent Exclusion Criteria: * Not compliant with criteria above * Unable to give informed consent
References
Publications (6)
- BACKGROUNDArrayeh E, Westphalen AC, Kurhanewicz J, Roach M 3rd, Jung AJ, Carroll PR, Coakley FV. Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93. doi: 10.1016/j.ijrobp.2011.11.030. Epub 2012 Feb 11. PMID 22331003
- BACKGROUNDBanerjee R, Park SJ, Anderson E, Demanes DJ, Wang J, Kamrava M. From whole gland to hemigland to ultra-focal high-dose-rate prostate brachytherapy: A dosimetric analysis. Brachytherapy. 2015 May-Jun;14(3):366-72. doi: 10.1016/j.brachy.2014.12.007. Epub 2015 Feb 10. PMID 25680768
- BACKGROUNDCrook J, Ots A, Gaztanaga M, Schmid M, Araujo C, Hilts M, Batchelar D, Parker B, Bachand F, Milette MP. Ultrasound-planned high-dose-rate prostate brachytherapy: dose painting to the dominant intraprostatic lesion. Brachytherapy. 2014 Sep-Oct;13(5):433-41. doi: 10.1016/j.brachy.2014.05.006. Epub 2014 Jun 20. PMID 24958556
- BACKGROUNDDa Rosa MR, Milot L, Sugar L, Vesprini D, Chung H, Loblaw A, Pond GR, Klotz L, Haider MA. A prospective comparison of MRI-US fused targeted biopsy versus systematic ultrasound-guided biopsy for detecting clinically significant prostate cancer in patients on active surveillance. J Magn Reson Imaging. 2015 Jan;41(1):220-5. doi: 10.1002/jmri.24710. Epub 2014 Jul 21. PMID 25044935
- BACKGROUNDMason J, Al-Qaisieh B, Bownes P, Thwaites D, Henry A. Dosimetry modeling for focal high-dose-rate prostate brachytherapy. Brachytherapy. 2014 Nov-Dec;13(6):611-7. doi: 10.1016/j.brachy.2014.06.007. Epub 2014 Jul 29. PMID 25085456
- BACKGROUNDRose JN, Crook JM, Pickles T, Keyes M, Morris WJ. Salvage low-dose-rate permanent seed brachytherapy for locally recurrent prostate cancer: Association between dose and late toxicity. Brachytherapy. 2015 May-Jun;14(3):342-9. doi: 10.1016/j.brachy.2015.01.002. Epub 2015 Feb 26.