N/A
Completed N=26
High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule
Source: ClinicalTrials.gov NCT01605097 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Average Mean Dose to 90% of DIL Volume — 13.25 Grays
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Mean Dose to 90% of DIL Volume |
13.25 | — |
| SECONDARY Acute Toxicity |
1.5 | — |
| SECONDARY Prostate Specific Antigen(PSA) Response at 5-years |
0.06 | — |
Eligibility Criteria
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 years
Data sourced from ClinicalTrials.gov (NCT01605097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.