Focal high-dose-rate brachytherapy in the treatment of patients diagnosed with low or favorable – intermediate-risk prostate cancer

The safety and efficacy of focal high-dose-rate brachytherapy in the treatment of patients diagnosed with low or favorable – intermediate-risk prostate cancer and compared with low-dose-rate brachytherapy and active surveillance

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16325499

Enrollment

150

Registered

2022-11-29

Start date

2023-01-01

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low or favorable – intermediate-risk prostate cancer Cancer

Interventions

A sealed envelope method of randomization will be used to assign participants to the following groups: Active Surveillance (AS) group This is a control group and a stan

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Aged 40 to 75 years old 2. Multiparametric magnetic resonance tomography (mpMRI) was performed, and the tumor was verified by transrectal ultrasound (TRUS) – mpMRI fusion guided biopsy together with systemic biopsy 3. Histologically confirmed low- or favorable intermediate-risk PCa from mpMRI visible lesions only that meet the following criteria and there is no disease found in systemic biopsy (PSA = 10 ng/ml; ISUP = 2; T1 – T2b) 4. Less than 25 % of biopsies were affected 5. The size of the prostate does not exceed 60 cm3 6. Index lesion is larger than 0.5 cm3 or 6 mm in diameter 7. IPSS score is not greater than 18 points 8. Agrees to participate in the study and signs the consent form

Exclusion criteria

Exclusion criteria: 1. Previous radical prostate cancer treatment 2. Proven extracapsular extension of disease 3. Metastatic tumors

Design outcomes

Primary

Measure	Time frame
1. Quality of life (QoL) measured using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients questionnaire (QLQ-C30) and an additional module for prostate cancer patients (PR25) at baseline, months 1 and 6 and then every 6 months until the end of the study 2. Erectile function measured using the international index of erectile function (IIEF-5) questionnaire at baseline, months 1 and 6 and then every 6 months until the end of the study 3. Urinary function measured using the international prostate symptom score (IPSS) and interpreting the results of uroflowmetry at baseline, months 1 and 6 and then every 6 months until the end of the study 4. Progression-free survival and time to recurrence measured using standard tests performed on subjects diagnosed with PCa including prostate-specific antigen level, PSA doubling time (PSADT), a mpMRI examination, and a systematic and targeted biopsy guided by TRUS-MRI fusion images at 12 months after inclusion and later on if there is a suspicion of progression. We will assume that there is disease progression when confirmation after TRUS-MRI fusion guided focal and/or a systematic 12-needle biopsy.	—

Measure

Time frame

1. Quality of life (QoL) measured using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients questionnaire (QLQ-C30) and an additional module for prostate cancer patients (PR25) at baseline, months 1 and 6 and then every 6 months until the end of the study 2. Erectile function measured using the international index of erectile function (IIEF-5) questionnaire at baseline, months 1 and 6 and then every 6 months until the end of the study 3. Urinary function measured using the international prostate symptom score (IPSS) and interpreting the results of uroflowmetry at baseline, months 1 and 6 and then every 6 months until the end of the study 4. Progression-free survival and time to recurrence measured using standard tests performed on subjects diagnosed with PCa including prostate-specific antigen level, PSA doubling time (PSADT), a mpMRI examination, and a systematic and targeted biopsy guided by TRUS-MRI fusion images at 12 months after inclusion and later on if there is a suspicion of progression. We will assume that there is disease progression when confirmation after TRUS-MRI fusion guided focal and/or a systematic 12-needle biopsy.

—

Secondary

Measure	Time frame
1. Early and late gastrointestinal and genitourinary radiation toxicities after focal treatment measured using the Radiation Therapy Oncology Group (RTOG) at baseline, months 1 and 6 and then every 6 months until the end of the study 2. Evaluation of the significance and importance of the in vivo dosimetry performed measured by comparing the actual dose of ionizing radiation administered to the patient during the focal HDR brachytherapy procedure and comparing it with the actual prescribed dose. Measurements will be performed using a dosimetric system created in the applied physics department of Vilnius University at the time of the focal HDR brachytherapy procedure	—

Measure

Time frame

1. Early and late gastrointestinal and genitourinary radiation toxicities after focal treatment measured using the Radiation Therapy Oncology Group (RTOG) at baseline, months 1 and 6 and then every 6 months until the end of the study 2. Evaluation of the significance and importance of the in vivo dosimetry performed measured by comparing the actual dose of ionizing radiation administered to the patient during the focal HDR brachytherapy procedure and comparing it with the actual prescribed dose. Measurements will be performed using a dosimetric system created in the applied physics department of Vilnius University at the time of the focal HDR brachytherapy procedure

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Countries

Lithuania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026