Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source

NCT ID: NCT06080113

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2037-06-30

Brief Summary

The purpose is to assess and describe the oncological and functional outcomes following the introduction of curative targeted focal brachytherapy of prostate cancer in Denmark.

Men with a single MRI-identifiable prostate cancer index-tumour who fulfil inclusion criteria and are candidates for curative treatment. Eligible men will undergo curative intended targeted focal brachytherapy for treatment of histologically confirmed prostate cancer.

The intervention will include Low- (LDR) or High (HDR) dose rate targeted focal brachytherapy of prostate cancer. Collection of data on safety, morbidity, side effects and quality of life. Collection of clinical data on treatment efficacy, progression, and mortality.

All patients will have a follow up of 10-years for oncological outcome, 5-years for acute- and late toxicity-, and 2-years for functional outcomes, respectively. The follow up will include clinical data, MRI, confirmatory biopsies, and questionnaires at specific fixed time points pre-and post-operatively after 1-3 days, 4-weeks, 3-, 6--, 9-, 12-, 18-, and 24-months followed by every 6 months up to 5-yr and then every year up to 10-yr follow-up.

Anticipated number of patients is 50 and regular analysis and reporting will be performed continuously. The first short-term analysis will be after 18-months of follow-up after confirmatory MRI and biopsies, and the final reporting will be after 10-years follow-up in 2035.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Curative targeted focal brachytherapy treatment for localized unifocal prostate-cancer

Group Type: EXPERIMENTAL

Focal Brachytherapy

Intervention Type: RADIATION

Targeted focal brachytherapy is an image-guided technique, where the radioactive source is placed only, and directly into the cancerous area of the prostate. The aim is to preserve the normal surrounding prostate gland tissue to limit treatment-related side effects to the adjacent anatomical structures. A multiparametric prostate MRI is used to identify, localize, and delineate the intraprostatic PCa tumour lesion and plan treatment. A specialized MRI-ultrasound image-fusion software combines the MRI-images with dynamic ultrasound performed in the operating room and is used to focally guide the placement of the radioactive source in the prostate cancer (PCa) tumour focus based on focal dosimetry calculations. A safety margin around the tumour is applied where it is possible to account for MRI tumour volume underestimation, microscopic spread, and treatment uncertainties.

Interventions

Focal Brachytherapy

Targeted focal brachytherapy is an image-guided technique, where the radioactive source is placed only, and directly into the cancerous area of the prostate. The aim is to preserve the normal surrounding prostate gland tissue to limit treatment-related side effects to the adjacent anatomical structures. A multiparametric prostate MRI is used to identify, localize, and delineate the intraprostatic PCa tumour lesion and plan treatment. A specialized MRI-ultrasound image-fusion software combines the MRI-images with dynamic ultrasound performed in the operating room and is used to focally guide the placement of the radioactive source in the prostate cancer (PCa) tumour focus based on focal dosimetry calculations. A safety margin around the tumour is applied where it is possible to account for MRI tumour volume underestimation, microscopic spread, and treatment uncertainties.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Age 40-80; Performance status 0-1; >10 yr. life expectancy
• Candidate for curative intended treatment
• PSA <20 ng/mL
• Clinical stage T1c or T2a
• Prostate anatomy suitable for focal brachytherapy
• MRI identified index tumour (PI-RADS 3-5) with PCa confirmed on biopsy
• A single index tumour focus with Gleason score 6 (>10 mm maximum cancer-core length [MCCL]), Gleason score 3+4 (any MCCL) or Gleason core 4+3 (<10 mm MCCL)
• Systematic biopsies (≥10-12 cores) with no or low volume Gleason score 6 (3+3) PCa only
• No severe urinary obstructive symptoms (e.g., urinary retention needing indwelling catheter)
• Fit to undergo all procedures in the protocol
• Included subjects should be able to participate in the planned follow-up (either on-site visits or telephone consultation accepted at specific time-points).
• Included subjects should be able to read and understand the study details, and provide written informed consent to participate

Exclusion Criteria

If any of the following criteria is present, the subject cannot participate in the study:

• Not a candidate for curative intended treatment (e.g., other active malignancy except for non-melanoma skin-cancer, life-expectancy <10 years, severe comorbidities etc.)
• Prior surgical or radiation treatment of PCa; Prior transurethral-resection (TUR-P) is not an exclusion criterion.
• Evidence/suspicion of extra prostatic extension on MRI
• Tumour focus >50% of one prostate half on MRI corresponding to stage >T2a
• Briganti 2018 score ≥7%
• PCa with intraductal carcinoma, cribriform pattern, or small cell component
• Any anatomical or clinical conditional not suitable for brachytherapy (e.g., imperforate anus, prostatitis, inflammatory bowel disease, severe calcifications etc.)
• Any contraindication for prostate MRI (e.g., claustrophobia, pacemaker, estimated glomerular filtration rate ≤30 mL/min/1.73m2)
• Reduction in MRI image quality that interferes with diagnosis caused by e.g., hip replacement surgery or other metal implants in the pelvic area.
• Any medical condition precluding procedures
• Any medication that may alter prostate morphology or alter MRI appearance (e.g., 5-alpha reductase inhibitors, prior androgen deprivation therapy [ADT])
• Subjects who are unwilling or unable to adhere to the study requirements (including treatment, required assessments and follow-up).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lars Boesen

MD, PhD, DMSci, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Boesen, MD,PhD,DMSci

Role: PRINCIPAL_INVESTIGATOR

Department of Urology

Locations

Department of Urology, Herlev University Hospital Herlev

Herlev, , Denmark

Countries

Denmark

Other Identifiers

H-22046020

Identifier Type: -

Identifier Source: org_study_id