Prostate CancerCAPFIRENCT06080113
Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source
A study testing Focal Brachytherapy in people with Prostate Cancer, run by Herlev Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to Jun 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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%
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Urology, Herlev University Hospital Herlev
Herlev, 2730
About this study
Official title: Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source - The Introduction of Prostate Cancer Targeted Focal Therapy Treatment in Denmark
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.
Read more
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
- Being tested
- Focal Brachytherapy
- Keywords
- MRI, Biopsy, Brachytherapy, Focal treatment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal BrachytherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Curative targeted focal brachytherapy treatment for localized unifocal prostate-cancer Receives: Radiation: Focal Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (7)
Number of patients with treatment related adverse events
Adverse events are assessed by
- CTCAEv5 (Common Terminology Criteria for Adverse Events) changes from baseline to post-treatment; Grading 0-5. Higher scores mean worse outcome
The CTCAEv5 will be assessed before treatment, 1-3 days postoperatively, and at routine post-treatment follow-up visits (see below) up to two years following treatment, or at any time upon withdrawal or pathological or biochemical failure.
Measured: 24-months post treatment
Number of patients with treatment related urinary dysfunction
Adverse events are assessed by
- IPSS (International Prostate Symptom Score) changes from baseline to post-treatment; Grading 0-35.Higher scores mean worse outcome
The abovementioned toxicity-questionnaire will be assessed before treatment, 1-3 days postoperatively, and at routine post-treatment follow-up visits (see below) up to two years following treatment, or at any time upon withdrawal or pathological or biochemical failure.
Measured: 24-months post treatment
Number of patients with treatment related erectile dysfunction
Adverse events are assessed by
- IIEF-5 questionnaire (International Index of Erectile Dysfunction) changes from baseline to post-treatment; Grading 5-25. Higher scores mean worse outcome
The abovementioned questionnaire will be assessed before treatment, 1-3 days postoperatively, and at routine post-treatment follow-up visits (see below) up to two years following treatment, or at any time upon withdrawal or pathological or biochemical failure.
Measured: 24-months post treatment
Number of patients with treatment related bowel dysfunction
Adverse events are assessed by
- EPIC bowel domain questionnaire (Extended Prostate Cancer Index - Bowel function) changes from baseline to post-treatment; Grading 0-24.Higher scores mean worse outcome
The abovementioned questionnaire will be assessed before treatment, 1-3 days postoperatively, and at routine post-treatment follow-up visits (see below) up to two years following treatment, or at any time upon withdrawal or pathological or biochemical failure.
Measured: 24-months post treatment
Number of patients with treatment related quality of life changes
Adverse events are assessed by
SF-12 v2 questionnaire (Short Form Quality of life assessment) changes from baseline to post-treatment; Grading 12-56.Higher scores mean worse outcome
The abovementioned questionnaire will be assessed before treatment, 1-3 days postoperatively, and at routine post-treatment follow-up visits (see below) up to two years following treatment, or at any time upon withdrawal or pathological or biochemical failure.
Measured: 24-months post treatment
Number of patients with clinical progression at 3-, 5- and 10-yrs
Clinical progression can be defined as either biochemical- or pathological progression. Biochemical progression is defined as prostate-specific-antigen (PSA) increase >2 over nadir with an increase >0.75 ng/ml per year. PSA levels will be analyzed prior to routine post-treatment follow-up visits. First appointment is planned at 4 weeks following treatment, then three-monthly for 12 months, six-monthly up to five years post treatment, then yearly until ten years following treatment, or at any time upon withdrawal. In case of biochemical failure, a repeat MRI + biopsies are performed. Due to potential risk of PSA fluctuations ("PSA bounce") during the first 18-24 months following implantation, biochemical progression will not be defined before the primary outcome has been assessed 18 months post-treatment. Secondary definitions of biochemical failure such as PSA-density nadir + 0.1 ng/mL/cc will be analyzed. Pathological progression is defined as under primary outcome.
Measured: 10 years post-treatment
Rate of salvage treatment
The rate of salvage therapy is defined by the percentage of men who receive salvage treatment because of local disease progression following targeted focal brachytherapy. Salvage therapy may include (but not limited to) whole-gland radical prostatectomy, external beam radiation therapy, or re-treatment using focal brachytherapy.
Measured: 10 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Nov 2023
- Primary completionMay 2027 (estimated)
- Study completionJun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Boesen, Herlev Hospital
- Investigators
- Lars Boesen, MD,PhD,DMSci, Principal investigator, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080113
- Sponsor's protocol ID
- H-22046020
- Acronym
- CAPFIRE
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source - The Introduction of Prostate Cancer Targeted Focal Therapy Treatment in Denmark
- ClinicalTrials.gov ID
- NCT06080113
- Acronym / sponsor ID
- CAPFIRE / H-22046020
- Conditions
- Prostate Cancer
- Keywords
- MRI, Biopsy, Brachytherapy, Focal treatment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2037 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Radiation: Focal BrachytherapyCurative targeted focal brachytherapy treatment for localized unifocal prostate-cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focal BrachytherapyTargeted 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. | Radiation | Treatment group |
Primary outcome
Number of patients with local treatment control at 18-month post treatment
Time frame: 18 months
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).
7 secondary outcomes
Number of patients with treatment related adverse events
Time frame: 24-months post treatment
Number of patients with treatment related urinary dysfunction
Time frame: 24-months post treatment
Number of patients with treatment related erectile dysfunction
Time frame: 24-months post treatment
Number of patients with treatment related bowel dysfunction
Time frame: 24-months post treatment
Number of patients with treatment related quality of life changes
Time frame: 24-months post treatment
Number of patients with clinical progression at 3-, 5- and 10-yrs
Time frame: 10 years post-treatment
Rate of salvage treatment
Time frame: 10 years post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Boesen, MD,PhD,DMSci principal investigator
Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal Brachytherapy in people with Prostate Cancer, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with local treatment control at 18-month post treatment (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.