Clinical trial · Interventional
High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule
High Dose Rate Prostate (HDR) Brachytherapy Dose Escalation to Dominant Intra-prostatic Nodule for Patients With Intermediate and High Risk Prostate Cancer
- 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)
This study will investigate the feasibility of using technology of ultrasound guided HDR brachytherapy to focally increase dose to regions within the prostate that are heavily infiltrated with cancer. Such regions, referred to as dominant intraprostatic lesions (DIL) can be visualized using diffusion contrast enhanced MRI employing an endo-rectal coil. The magnetic resonance (MR) images can be fused with the planning transrectal ultrasound (TRUS) prior to the brachytherapy procedure to design a dose distribution that will encompass the malignant volume with higher than the prescription dose. By its nature, brachytherapy has subvolumes that receive (for example)125% of the prescription dose or 150% of the prescription dose. With TRUS-guided and TRUS-planned HDR these areas can be manipulated to coincide with the DIL. The limit of dose escalation has been reached at whole prostate external beam doses of 81-86 Gy and still failure rates for intermediate and high risk disease are unacceptable. There is much interest in focal dose escalation and TRUS-guided HDR brachytherapy is perfectly suited to achieving this.
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 |
|---|---|---|---|
| HDR interstitial brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HDR interstitial brachytherapy
- description
- HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion
- interventionNames
- Radiation: HDR interstitial brachytherapy
Primary outcomes (1)
- measure
- Average Mean Dose to 90% of DIL Volume
- timeFrame
- 12 months
- description
- Feasibility of dose escalation to a minimum dose of 125% of prescription to 90% of the dominant intra-porstatic lesion (DIL) volume as defined on multiparametric endo-rectal magnetic resonance imaging (mpMRI) without exceeding critical organ dose constraints (Urethral volume receiving 115%= 0, Dose to 1cc of rectal wall \< 7 Gy). 2 Fractions were performed and the mean dose to 90% of DIL volume was averaged.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
* histologically proven adenocarcinoma of the prostate
* intermediate or high risk prostate cancer
* Intermediate risk prostate cancer patients must have:
* Clinical stage ≤ T2c,
* Gleason score = 7 and initial prostate specific antigen (iPSA) ≤ 20, or
* Gleason score ≤ 6 and iPSA \> 10 and ≤ 20.
* High risk patients may have
* Clinical stage T3
* Gleason score 8-10
* PSA \> 20 ng/ml
* fit for general anesthetic.
* unilateral disease with either a palpable nodule or a cluster of positive biopsies from a single region suggesting the presence of dominant nodule.
* estimated life expectancy of at least 10 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
* no contraindications to interstitial prostate brachytherapy.
* if on coumadin therapy must be able to stop safely for 7 days.
* must not have any contraindications to MRI
Exclusion Criteria:
* Does not meet staging criteria for intermediate or high risk prostate cancer
* Does not have a localized high volume of intraprostatic disease
* unfit for general anesthetic
* MRI contraindicated
* unable to stop blood thinners
* Life expectancy \< 10 yearsReferences
Publications (4)
- BACKGROUNDGroenendaal G, van den Berg CA, Korporaal JG, Philippens ME, Luijten PR, van Vulpen M, van der Heide UA. Simultaneous MRI diffusion and perfusion imaging for tumor delineation in prostate cancer patients. Radiother Oncol. 2010 May;95(2):185-90. doi: 10.1016/j.radonc.2010.02.014. Epub 2010 Mar 16. PMID 20231041
- BACKGROUNDKim Y, Hsu IC, Lessard E, Kurhanewicz J, Noworolski SM, Pouliot J. Class solution in inverse planned HDR prostate brachytherapy for dose escalation of DIL defined by combined MRI/MRSI. Radiother Oncol. 2008 Jul;88(1):148-55. doi: 10.1016/j.radonc.2007.11.024. Epub 2008 Feb 20. PMID 18083260
- BACKGROUNDPouliot J, Kim Y, Lessard E, Hsu IC, Vigneron DB, Kurhanewicz J. Inverse planning for HDR prostate brachytherapy used to boost dominant intraprostatic lesions defined by magnetic resonance spectroscopy imaging. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1196-207. doi: 10.1016/j.ijrobp.2004.02.055. PMID 15234056
- DERIVEDDe Bari B, Daidone A, Alongi F. Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. Crit Rev Oncol Hematol. 2015 Jun;94(3):360-70. doi: 10.1016/j.critrevonc.2015.02.003. Epub 2015 Feb 17. PMID 25819287