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Partial Prostate Salvage High Dose Rate Brachytherapy (SalvageHDR)

Primary Purpose

Recurrent Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HDR partial prostate brachytherapy
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Prostate Cancer focused on measuring recurrent prostate cancer, mpMRI, salvage HDR brachytherapy

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >45 and Life expectancy >10 years
  • Previous External Beam Radiotherapy (EBRT) dose up to 78Gray/39 fractions, 81 Gray/45 fractions or 70 Gray/28 fractions
  • > 3 year interval since EBRT
  • No late toxicity from prior EBRT > grade 2
  • Rising PSA post EBRT > nadir + 2 ng/ml but < 10 ng/ml
  • PSA Doubling time > 6 months
  • Negative staging with CT scan of the abdomen/pelvis and bone scan
  • Able to undergo multiparametric MRI with endorectal coil
  • Radiographic evidence of dominant intraprostatic lesion (DIL) as only area of recurrence (i.e unifocal recurrence) and corresponding to site of original disease
  • Biopsy confirmation of DIL with pathology review by British Columbia Cancer Agency GenitoUrinary pathologist (TB)
  • Willing to provide informed consent
  • History and physical examination within 90 days of registration
  • ECOG performance status 0-1 prior to registration
  • IPSS < 16, or adequate voiding study (post void residual < 100cc and peak flow rate > 10 cc/second).
  • No prior trans urethral prostatic resection
  • Recurrence suitable for implant with HDR brachytherapy as assessed on ultrasound simulation (maximum PTV ideally < 65% of prostate volume)
  • No history of inflammatory bowel disease or previous rectal surgery
  • Suitable for procedure under anesthesia, spinal or general
  • INR <2.5 and platelet count >75 x 109/L
  • Androgen Deprivation Therapy may be initiated at the discretion of the treating oncologist

Exclusion Criteria:

  • Not compliant with criteria above
  • Unable to give informed consent

Sites / Locations

  • BCCA Center for the Southern InteriorRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HDR partial prostate brachytherapy

Arm Description

2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI

Outcomes

Primary Outcome Measures

Late adverse gastrointestinal or genitourinary events grade 3 or higher
Common Terminology Criteria for Adverse Events (CTCAE V4.0)

Secondary Outcome Measures

Late Quality of Life
Expanded Prostate Cancer Index (EPIC)
Late lower urinary tract symptoms
International Prostate Symptom Score
Acute grade 3 or higher gastrointestinal or genitourinary adverse events
Common Terminology Criteria for Adverse Events (CTCAE V4.0)
Acute Quality of Life changes
Expanded Prostate Cancer Index (EPIC)
Acute lower urinary symptoms
International Prostate Symptoms Score
Biochemical disease free survival
PSA < 0.4 ng/ml at 60 months

Full Information

First Posted
August 3, 2017
Last Updated
June 29, 2021
Sponsor
British Columbia Cancer Agency
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1. Study Identification

Unique Protocol Identification Number
NCT03246802
Brief Title
Partial Prostate Salvage High Dose Rate Brachytherapy
Acronym
SalvageHDR
Official Title
High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Columbia Cancer Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Appropriately selected patients with histologically documented recurrence 3 years or more after initial external beam radiotherapy will undergo mpMRI for identification of the site of recurrence. A planning transrectal ultrasound (TRUS) will be obtained for fusion with the mpMRI and transposition of the target volume (GTV=gross tumor volume). A margin of 4.5 cm will be added to the GTV to create a focal planning target volume (PTV). The margin may be cropped at the interface with critical organs. Two fractions of HDR brachytherapy will be delivered, each from a single implant, 2 weeks apart. Following treatment patients will be monitored for toxicity and quality of life using the Expanded Prostate cancer Index (EPIC) questionnaire as well as the International Prostate Symptom score. Efficacy will be evaluated by monitoring the Prostate Specific Antigen (PSA) and repeat mpMRI at 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Prostate Cancer
Keywords
recurrent prostate cancer, mpMRI, salvage HDR brachytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
High Dose Rate brachytherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HDR partial prostate brachytherapy
Arm Type
Experimental
Arm Description
2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI
Intervention Type
Radiation
Intervention Name(s)
HDR partial prostate brachytherapy
Intervention Description
temporary radioactive implant
Primary Outcome Measure Information:
Title
Late adverse gastrointestinal or genitourinary events grade 3 or higher
Description
Common Terminology Criteria for Adverse Events (CTCAE V4.0)
Time Frame
3-60 months
Secondary Outcome Measure Information:
Title
Late Quality of Life
Description
Expanded Prostate Cancer Index (EPIC)
Time Frame
3-60 months
Title
Late lower urinary tract symptoms
Description
International Prostate Symptom Score
Time Frame
3-60 months
Title
Acute grade 3 or higher gastrointestinal or genitourinary adverse events
Description
Common Terminology Criteria for Adverse Events (CTCAE V4.0)
Time Frame
0-3 months
Title
Acute Quality of Life changes
Description
Expanded Prostate Cancer Index (EPIC)
Time Frame
0-3 months
Title
Acute lower urinary symptoms
Description
International Prostate Symptoms Score
Time Frame
0-3 months
Title
Biochemical disease free survival
Description
PSA < 0.4 ng/ml at 60 months
Time Frame
60 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >45 and Life expectancy >10 years Previous External Beam Radiotherapy (EBRT) dose up to 78Gray/39 fractions, 81 Gray/45 fractions or 70 Gray/28 fractions > 3 year interval since EBRT No late toxicity from prior EBRT > grade 2 Rising PSA post EBRT > nadir + 2 ng/ml but < 10 ng/ml PSA Doubling time > 6 months Negative staging with CT scan of the abdomen/pelvis and bone scan Able to undergo multiparametric MRI with endorectal coil Radiographic evidence of dominant intraprostatic lesion (DIL) as only area of recurrence (i.e unifocal recurrence) and corresponding to site of original disease Biopsy confirmation of DIL with pathology review by British Columbia Cancer Agency GenitoUrinary pathologist (TB) Willing to provide informed consent History and physical examination within 90 days of registration ECOG performance status 0-1 prior to registration IPSS < 16, or adequate voiding study (post void residual < 100cc and peak flow rate > 10 cc/second). No prior trans urethral prostatic resection Recurrence suitable for implant with HDR brachytherapy as assessed on ultrasound simulation (maximum PTV ideally < 65% of prostate volume) No history of inflammatory bowel disease or previous rectal surgery Suitable for procedure under anesthesia, spinal or general INR <2.5 and platelet count >75 x 109/L Androgen Deprivation Therapy may be initiated at the discretion of the treating oncologist Exclusion Criteria: Not compliant with criteria above Unable to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juanita Crook, MD
Phone
2507123958
Email
jcrook@bccancer.bc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Francois Bachand, MD
Phone
2507123900
Email
fbachand@bccancer.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mira Keyes, MD
Organizational Affiliation
BCCA
Official's Role
Study Director
Facility Information:
Facility Name
BCCA Center for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juanita Crook, MD
Phone
250 712 3958
Email
jcrook@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Francois Bachand, MD
Phone
250 712 3900
Email
fbachand@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Juanita Crook, MD
First Name & Middle Initial & Last Name & Degree
Deidre Batchelar, PhD
First Name & Middle Initial & Last Name & Degree
Michelle Hilts, PhD
First Name & Middle Initial & Last Name & Degree
Marie-Pierre Milette, PhD
First Name & Middle Initial & Last Name & Degree
Ross Halperin, MD
First Name & Middle Initial & Last Name & Degree
David Petrik, MD
First Name & Middle Initial & Last Name & Degree
David Kim, MD
First Name & Middle Initial & Last Name & Degree
Brenda Farnquist, MD
First Name & Middle Initial & Last Name & Degree
Terry Bainbridge, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22331003
Citation
Arrayeh 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.
Results Reference
background
PubMed Identifier
25680768
Citation
Banerjee 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.
Results Reference
background
PubMed Identifier
24958556
Citation
Crook 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.
Results Reference
background
PubMed Identifier
25044935
Citation
Da 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.
Results Reference
background
PubMed Identifier
25085456
Citation
Mason 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.
Results Reference
background
PubMed Identifier
25727178
Citation
Rose 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.
Results Reference
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Partial Prostate Salvage High Dose Rate Brachytherapy

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