NCT03246802

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
129mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2018Jan 2037

First Submitted

Initial submission to the registry

August 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2032

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2037

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

14 years

First QC Date

August 3, 2017

Last Update Submit

January 29, 2026

Conditions

Recurrent Prostate Cancer

Keywords

recurrent prostate cancermpMRIsalvage HDR brachytherapy

Outcome Measures

Primary Outcomes (1)

  • Late adverse gastrointestinal or genitourinary events grade 3 or higher

    Common Terminology Criteria for Adverse Events (CTCAE V4.0)

    3-60 months

Secondary Outcomes (7)

  • Late Quality of Life

    3-60 months

  • Late lower urinary tract symptoms

    3-60 months

  • Acute grade 3 or higher gastrointestinal or genitourinary adverse events

    0-3 months

  • Acute Quality of Life changes

    0-3 months

  • Acute lower urinary symptoms

    0-3 months

  • +2 more secondary outcomes

Study Arms (1)

HDR partial prostate brachytherapy

EXPERIMENTAL

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

Radiation: HDR partial prostate brachytherapy

Interventions

HDR partial prostate brachytherapyRADIATION

temporary radioactive implant

HDR partial prostate brachytherapy

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 or LDR brachytherapy with site of recurrence in an under-dosed or untreated site
  • \> 3 year interval since EBRT or LDR Brachytherapy
  • 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 (PSMA PET scan can replace CT 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
  • +5 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BCCA Center for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

RECRUITING

Related Publications (6)

  • 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.

    PMID: 22331003BACKGROUND

  • 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.

    PMID: 25680768BACKGROUND

  • 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.

    PMID: 24958556BACKGROUND

  • 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.

    PMID: 25044935BACKGROUND

  • 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.

    PMID: 25085456BACKGROUND

  • 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.

    PMID: 25727178BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Mira Keyes, MD

    BCCA

    STUDY DIRECTOR

Central Study Contacts

Juanita Crook, MD

CONTACT

2507123958jcrook@bccancer.bc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: High Dose Rate brachytherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiation Oncology

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 11, 2017

Study Start

January 1, 2018

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2037

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)