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Recurrent Prostate CancerSalvageHDRNCT03246802

Partial Prostate Salvage High Dose Rate Brachytherapy

A study testing HDR partial prostate brachytherapy in people with Recurrent Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older, men only
Conditions the study is for
Recurrent Prostate Cancer
What is being tested?
HDR partial prostate brachytherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
1 Jan 2018to 1 Jan 2037
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juanita Crook, MD contact

2507123958

jcrook@bccancer.bc.ca

Canada1 site, 1 recruiting

  • BCCA Center for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

    Juanita Crook, MD, 250 712 3958, jcrook@bccancer.bc.ca

    Juanita Crook, MD

    Recruiting

Other trials in Canada

About this study

Official title: High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy

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..

Being tested
HDR partial prostate brachytherapy
Keywords
recurrent prostate cancer, mpMRI, salvage HDR brachytherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HDR partial prostate brachytherapyRadiation

    temporary radioactive implant

Study groups in NCT03246802
Study groupRoleWhat they receive
HDR partial prostate brachytherapyExperimental2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI
Receives: Radiation: HDR partial prostate brachytherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 3-60 months

Secondary outcomes (7)

  1. Late Quality of Life

    Expanded Prostate Cancer Index (EPIC)

    Measured: 3-60 months

  2. Late lower urinary tract symptoms

    International Prostate Symptom Score

    Measured: 3-60 months

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

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

    Measured: 0-3 months

  4. Acute Quality of Life changes

    Expanded Prostate Cancer Index (EPIC)

    Measured: 0-3 months

  5. Acute lower urinary symptoms

    International Prostate Symptoms Score

    Measured: 0-3 months

  6. Biochemical disease free survival

    PSA < 0.4 ng/ml at 60 months

    Measured: 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2017
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2032 (estimated)
  4. Study completion1 Jan 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
High Dose Rate brachytherapy
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03246802
Sponsor's protocol ID
H17-01641
Acronym
SalvageHDR
Status last verified
Jun 2026
First submitted
3 Aug 2017
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing HDR partial prostate brachytherapy in people with Recurrent Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juanita Crook, MD (2507123958, jcrook@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late adverse gastrointestinal or genitourinary events grade 3 or higher (time frame: 3-60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03246802, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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