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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.
Methods: If a dominant nodule is visualized on dynamic contrast enhanced (DCE) MRI, it will be contoured in 3D and the images fused to the planning TRUS study that is done in preparation for brachytherapy (of any type: seeds or HDR). The patient's treatment will consist of the standard combined external beam (4600 centiGray (cGy) in 23 fractions) and HDR brachytherapy boost (2 fractions of 1000 cGy given on days 5 and 15 of the external beam course). During each HDR treatment the plan will be manipulated such that the normally occurring high dose regions (125%, 150%) are positioned at the site of the identified disease. Normally approximately 60% of the prostate volume receives 125% of the dose and 30% receives 150%. By ensuring that the inherent dosimetry favors treatment of the known cancer, no region of the prostate would be "underdosed". HDR treatments are performed under general anesthesia as an out patient procedure.
Statistical Analysis: This is a feasibility study and the data reported will be descriptive including the frequency with which the DIL can be visualized in this population, the DIL volume compared to total prostate volume, and the isodose that can encompass the DIL without violating dose constraints to adjacent organs (urethra and bladder). Toxicity will be monitored and efficacy will be assessed by repeat DCE MRI at 12 months and biopsy at 30 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDR interstitial brachytherapy | Experimental | HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDR interstitial brachytherapy | Radiation | 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Mean Dose to 90% of DIL Volume | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicity | Time to normalize International Prostate Symptom Score (months). Score range 0-35 with 35 being worst outcome. Normalization refers to a return to baseline urinary function prior to treatment. | 24 months |
| Prostate Specific Antigen(PSA) Response at 5-years |
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Inclusion Criteria:
histologically proven adenocarcinoma of the prostate
intermediate or high risk prostate cancer
Intermediate risk prostate cancer patients must have:
High risk patients may have
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:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Schmid, MSc | Medical Physicst | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center for the Southern Interior | Kelowna | British Columbia | V1Y5L3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20231041 | Background | Groenendaal 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. | |
| 18083260 | Background |
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One patient consented but ineligible because did not have a visible lesion on the MRI of his prostate.
Aim of protocol was to have 25 patients for whom dominant lesion identified on MRI and dose escalation feasible with HDR brachytherapy
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Rate (HDR) Interstitial Brachytherapy | HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HDR Interstitial Brachytherapy | HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Mean Dose to 90% of DIL Volume | 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. | Posted | Mean | Standard Deviation | Grays | 12 months |
|
Data collected for 60 months on all patients. Accrual was completed July 2013 and data collected to July 2018.
CTCAE V 3.0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HDR Interstitial Brachytherapy | HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| late hematuria grade 1 | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Juanita Crook | BC Cancer | 250 712 3958 | jcrook@bccancer.bc.ca |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
Efficacy assessed by biochemical PSA response reported at median 5 year follow up. |
| 5 years |
| Kim 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. |
| 15234056 | Background | Pouliot 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. |
| 25819287 | Derived | De 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline PSA ng/mL | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. | Median | Full Range | ng/mL |
|
| Gleason score | Gleason score is assigned by pathologist on examination of prostate biopsy material and ranges from 2 to 10 with higher score representing more aggressive undifferentiated tumors | Number | participants |
|
| clinical stage | Clinical Tumor Stage is assigned from combination of digital rectal exam and imaging. T1 representants tumor that is neither palpable nor visible on imaging. cT2a and cT2b represent palpable/visible disease that is either less than half of one lobe (cT2a) or more than half of one lobe(cT2b). | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Acute Toxicity | Time to normalize International Prostate Symptom Score (months). Score range 0-35 with 35 being worst outcome. Normalization refers to a return to baseline urinary function prior to treatment. | Months to normalization of International Prostate Symptom Score following treatment. | Posted | Median | Full Range | months | 24 months |
|
|
|
| Secondary | Prostate Specific Antigen(PSA) Response at 5-years | Efficacy assessed by biochemical PSA response reported at median 5 year follow up. | All 25 underwent dose escalation to dominant lesion in prostate to median 132% of prescription dose | Posted | Median | Full Range | ng/ml | 5 years |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 5 |
| 25 |
| grade 1 proctitis | Gastrointestinal disorders | Non-systematic Assessment | rectal discomfort, no intervention required |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |