Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy (BrachyQOL)

British Columbia Cancer Agency

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Radiation: LDR; Radiation: HDR

Study type: Interventional

Funder types: Other

Identifiers

NCT01936883

H13-02139

Details and patient eligibility

About

Optimal non surgical treatment of prostate cancer requires dose escalation which is frequently provided by adding a brachytherapy "boost" to a short course of external beam radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR) brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA) recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that it is associated with a more favorable toxicity profile and improved quality of life.

Full description

Men with intermediate or high risk prostate cancer who are technically suitable for prostate brachytherapy based on prostate size and voiding function and who are interested in this modality of treatment will be approached for randomization between either high dose rate (single 15 Gray) or low dose rate permanent seed implant (110 Gray) brachytherapy. Baseline International Prostate Symptom score, Quality of Life Assessment and International Index of Erectile Function will be recorded and then every 3 months for the first year and every 6 months to 3 years. Androgen deprivation treatment is allowed for 6 or 12 months.

Enrollment: 195 patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Upper tier intermediate risk with at least 2 of the following factors

  1. Tumor-Nodes-Metastases Tumor stage T2B or greater
  2. Gleason Score 7
  3. PSA > 10
  4. > 50% of the biopsies positive

• OR High risk prostate cancer with one of the following factors

  1. T3a
  2. Gleason Score8-10
  3. PSA >20

• Positive prostate biopsy within 12 months (reviewed centrally)

• International Prostate Symptom Score < 16

• Prostate volume < 60 cc

• Negative staging CT and Bone scan within 3 months prior to registration

• History and physical examination within 90 days prior to registration

• European Cooperative Oncology Group performance status 0-1 prior to registration

• Age >45

• Patient suitable for procedure under anesthesia

Exclusion criteria

• Prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration
• Previous prostatectomy, cryotherapy or High Intensity Focussed Ultrasound for prostate cancer
• Previous pelvic irradiation or prostate brachytherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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195 participants in 2 patient groups

LDR boost

Active Comparator group

Description:

After completion of 46 Gy of external beam radiotherapy subjects will undergo a permanent seed radioactive implant to the prostate using iodine-125 seeds to deliver a dose of 110 Gy

Treatment:

Radiation: LDR

HDR boost

Active Comparator group

Description:

Subjects in this arm will undergo an HDR implant to deliver 15 Gy to the prostate prior to commencing the external beam component of their treatment.

Treatment:

Radiation: HDR