LDR vs. HDR Brachytherapy for Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03426748
• Date of registration: 02/02/2018
• Prospective Registration: Yes
• Primary sponsor: British Columbia Cancer Agency
• Public title: LDR vs. HDR Brachytherapy for Prostate Cancer LDR/HDRmono
• Scientific title: A Phase III Randomized Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer
• Date of first enrolment: February 15, 2018
• Target sample size: 140
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03426748
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Ross Halperin, MD
• Affiliation: British Columbia Cancer Agency Program Director

• Name: Juanita M Crook, MD

• Name: Juanita Crook, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

Favorable risk and low-tier intermediate-risk prostate cancer with estimated life
expectancy of at least 10 years.

- Clinical stage T1c-T2b, PSA < 20, Gleason < 8

- ECOG 0-1

- Low tier intermediate-risk prostate cancer is defined by a single NCCN intermediate
risk factor

- Extensive favorable-risk disease is defined as:

- clinical stage T1c-T2a

- PSA < 10

- Gleason 6

- = 50% of biopsy cores containing cancer

- PSA density > 0.2 ng/cc

- Selected intermediate risk patients not defined above

- - T1c/T2a

- - PSA < 10

- -Gleason 4+3

- -< 33% of cores involved

- -Max tumor length in any core 10 mm

- No androgen deprivation therapy (ADT)

- Prostate volume by TRUS = 60 cc.

- Not eligible for, or accepting of, active surveillance according to NCCN guidelines.

- Signed study specific informed consent.

Exclusion Criteria:

- Prior radical surgery for carcinoma of the prostate,

- Prior pelvic radiation

- Prior chemotherapy for prostate cancer,

- Prior TURP or cryosurgery of the prostate

- Claustrophobic or unable to undergo MRI



Age minimum: 40 Years
Age maximum: 80 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Radiation: High dose rate prostate brachytherapy

Radiation: Low dose rate prostate brachytherapy

Primary Outcome(s)

The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy. [Time Frame: 0-36 months]

Secondary Outcome(s)

Time to return to baseline +/- 3 points for the International Prostate Symptom Score [Time Frame: 0-36 months]

Cell cycle progression score [Time Frame: 1 month to 10 years]

Biochemical Outcome [Time Frame: 5-10 years]

Quality of Life in the bowel and sexual domains [Time Frame: 0-36 months]

Tumor oxygenation and cell cycle distribution [Time Frame: 1 month to 10 years.]

Acute and long term toxicity [Time Frame: [Time Frame: 0-10 years]]

Histologic Outcome [Time Frame: 3 years]

Secondary ID(s)

H17-02904

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

BC Cancer Foundation