Recruiting

Brachytherapy

Sponsor:

British Columbia Cancer Agency

Code:

NCT03246802

Conditions

Recurrent Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

Interventions

HDR partial prostate brachytherapy

Study Details

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.

Conditions

Recurrent Prostate Cancer

Study ID

NCT03246802

Start date

Jan 1, 2018

Status verified date

Jun, 2026

Completion date

Jan 1, 2037

Anticipated

Primary completion date

Jan 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

HDR partial prostate brachytherapy

temporary radioactive implant

Primary outcome measure

  • Late adverse gastrointestinal or genitourinary events grade 3 or higher [ Time Frame: 3-60 months ]

Central Contacts and Locations

Central contacts

Juanita Crook, MD

2507123958jcrook@bccancer.bc.ca

Locations

BCCA Center for the Southern Interior

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

Contacts

Juanita Crook, MD

250 712 3958jcrook@bccancer.bc.ca

Principal Investigator:

Juanita Crook, MD

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • recurrent prostate cancer
  • mpMRI
  • salvage HDR brachytherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2026-06-29.