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NCT Number: NCT03246802

Partial Prostate Salvage High Dose Rate Brachytherapy

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.

Recruiting

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Key information

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

BCCA Center for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location status: Recruiting

Location contact

Brenda Farnquist, MD

SUB_INVESTIGATOR

David Kim, MD

SUB_INVESTIGATOR

David Petrik, MD

SUB_INVESTIGATOR

Deidre Batchelar, PhD

SUB_INVESTIGATOR

Juanita Crook, MD

CONTACT

[email protected]

250 712 3958

Juanita Crook, MD

PRINCIPAL_INVESTIGATOR

Ross Halperin, MD

SUB_INVESTIGATOR

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDR partial prostate brachytherapy

Radiation

temporary radioactive implant

Primary outcomes

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

    Time frame: 3-60 months

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

Secondary outcomes

  1. Late Quality of Life

    Time frame: 3-60 months

    Expanded Prostate Cancer Index (EPIC)

  2. Late lower urinary tract symptoms

    Time frame: 3-60 months

    International Prostate Symptom Score

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

    Time frame: 0-3 months

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

  4. Acute Quality of Life changes

    Time frame: 0-3 months

    Expanded Prostate Cancer Index (EPIC)

  5. Acute lower urinary symptoms

    Time frame: 0-3 months

    International Prostate Symptoms Score

  6. Biochemical disease free survival

    Time frame: 60 months

    PSA < 0.4 ng/ml at 60 months

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

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Juanita Crook, MD

CONTACT

[email protected]

2507123958

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

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

Acronym: SalvageHDR

Important dates

Study start
2018
Primary completion
2032
Study completion
2037
First posted
Aug 11, 2017
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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