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RecruitingNCT03246802SalvageHDRUpdated Jun 29, 2026

Partial Prostate Salvage High Dose Rate Brachytherapy

An interventional study of HDR partial prostate brachytherapy in Recurrent Prostate Cancer, sponsored by British Columbia Cancer Agency. Recruiting at 1 site in Canada. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by British Columbia Cancer Agency · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
45 Years and older
Sex
Male
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Study 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.

Read the 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 if PSA is rising during follow-up, PSMA PET will be ordered when clinically indicated..

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Conditions studied

  • Recurrent Prostate Cancer

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Keywords

  • recurrent prostate cancer
  • mpMRI
  • salvage HDR brachytherapy
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 30 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Age >45 and Life expectancy >10 years
  • Previous External Beam Radiotherapy (EBRT) or LDR brachytherapy w
  • > 3 year interval since EBRT or LDR Brachytherapy
  • No late toxicity from prior EBRT ≥ grade 2
  • PSA > nadir + 2 ng/ml and \< 10 ng/ml
  • PSA Doubling time > 6 months
  • Radiographic evidence corresponding with site of recurrence in an under-dosed or untreated site. The recurrence should correspond to the site of original disease or be located in the seminal vesical +/- adjacent prostate as only area of recurrence (i.e. unifocal recurrence).
  • Per Investigator, recurrence is suitable for implant with HDR brachytherapy and patient is suitable for procedure under anesthesia, spinal or general.
  • Negative staging of the abdomen/pelvis and bones.
  • Willing to provide informed consent

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    HDR partial prostate brachytherapy

    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

  • RadiationHDR partial prostate brachytherapy

    temporary radioactive implant

06

What researchers measure

Primary outcomes

  1. Late adverse gastrointestinal or genitourinary events grade 3 or higher

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

    Time frame: 3-60 months

Secondary outcomes

  1. Late Quality of Life

    Expanded Prostate Cancer Index (EPIC)

    Time frame: 3-60 months

  2. Late lower urinary tract symptoms

    International Prostate Symptom Score

    Time frame: 3-60 months

  3. Acute grade 3 or higher gastrointestinal or genitourinary adverse events

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

    Time frame: 0-3 months

  4. Acute Quality of Life changes

    Expanded Prostate Cancer Index (EPIC)

    Time frame: 0-3 months

  5. Acute lower urinary symptoms

    International Prostate Symptoms Score

    Time frame: 0-3 months

  6. Biochemical disease free survival

    PSA \< 0.4 ng/ml at 60 months

    Time frame: 60 months

  7. Number of participants with site of failure determined by PSMA PET Scan at the time of rising PSA.

    Number of participants with site of failure determined by PSMA PET Scan at the time of rising PSA.

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • BCCA Center for the Southern Interior
    Kelowna, British Columbia V1Y 5L3, Canada
    • Juanita Crook, MD · Contact · jcrook@bccancer.bc.ca · 250 712 3958
    • Juanita Crook, MD · Principal investigator
    • Deidre Batchelar, PhD · Sub investigator
    • Ross Halperin, MD · Sub investigator
    • David Petrik, MD · Sub investigator
    • David Kim, MD · Sub investigator
    • Brenda Farnquist, MD · Sub investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 22331003 ↗
  • 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. PubMed 25680768 ↗
  • 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. PubMed 24958556 ↗
  • 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. PubMed 25044935 ↗
  • 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. PubMed 25085456 ↗
  • 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. PubMed 25727178 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03246802
Lead sponsor
British Columbia Cancer Agency
Responsible party
Juanita Crook (Professor of Radiation Oncology, British Columbia Cancer Agency) — Principal investigator
First posted
Aug 11, 2017
Start date
Jan 1, 2018
Primary completion
Jan 1, 2032 (estimated)
Completion
Jan 1, 2037 (estimated)
Last update
Jun 29, 2026

Study contacts

Juanita Crook, MD
Contact
jcrook@bccancer.bc.ca
2507123958
Mira Keyes, MD
study director · BCCA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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