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

NCT06080113 | Enrolling By Invitation

• 1 other identifier: H-22046020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

MRI; Biopsy; Brachytherapy; Focal treatment

Outcome Measures

Primary Outcomes (1)

• Number of patients with local treatment control at 18-month post treatment

  An MRI followed by targeted prostate biopsies are performed 18 months post-treatment. Lack of pathological control (progression) is defined by: * No pathological changes on biopsy from baseline (stable disease); and/or * Tumour upgrading (increase in maximum cancer core length (measured in mm) or higher-grade tumour with increasing Gleason grade (aggressiveness score 1-5, where 5 is worst) compared to baseline. These two measurements will be aggregated to arrive at one reported value for the question: \- Pathological control at 18-month post treatment (yes/no).

  18 months

Secondary Outcomes (7)

• Number of patients with treatment related adverse events

  24-months post treatment

• Number of patients with treatment related urinary dysfunction

  24-months post treatment

• Number of patients with treatment related erectile dysfunction

  24-months post treatment

• Number of patients with treatment related bowel dysfunction

  24-months post treatment

• Number of patients with treatment related quality of life changes

  24-months post treatment

Study Arms (1)

Treatment group

EXPERIMENTAL

Curative targeted focal brachytherapy treatment for localized unifocal prostate-cancer

Radiation: Focal Brachytherapy

Interventions

Focal Brachytherapy 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.

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• 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).

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of Urology, Herlev University Hospital Herlev

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Lars Boesen, MD,PhD,DMSci

  Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DMSci, Associate Professor

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: October 12, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2037
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)