Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

patients undergoing MRI targeted prostate biopsy

patients undergoing focal treatment for localized prostate cancer (HIFU, NanoKnife, Cryotherapy)

David Margel, MD PhD

The main objective of this study is to determine whether focal-driven therapies for diagnosis and treatment of prostate cancer are preferable over current clinical methods. Different focal procedures will be examined, including magnetic resonance imaging (MRI)-target biopsy, and focal treatment as High Intensity Focused Ultrasound (HIFU), cryoablation and Nano-Knife.

Men who are scheduled to undergo a focal therapy will be given patient information sheet, which explains the study in lay terms. Fully informed consent, written or verbal (by phone) will be sought and documented before collecting any research data.

The following information will be collected for all patients:

* Demographic data: date of birth, age, gender, ethnicity, Height, weight.
* Medical History: number and results of previous biopsies, previous Protein Specific Antigen (PSA) tests.

For patients who have undergone or are scheduled to undergo MRI-US FUSION biopsy, the following information will be collected:

* MRI: MRI protocol, MRI results: suspected lesions, apparent diffusion coefficient (ADC) values.
* Biopsy procedure details and results: duration and success of procedure, number of cores taken, pathological results, following treatment (if applicable).

For patients who have undergone or are scheduled to undergo HIFU or Nano-Knife or Cryotherapy the following data will be collected:

* Procedure details.
* Evaluation of success: results of following PSA test, MRI and/or prostate biopsy.

Patients undergoing HIFU, Nano-Knife or Cryotherapy will also be asked to complete two questionnaires: IPSS, a validated lower urinary tract symptom questionnaire, and IIEF, a validated erectile function questionnaire.

participant eligibility is based on gender identity.

Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy

Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy

PSA will be taken every 3 months during the first year after procedure, and every 6 months in the next following 4 years

clinically significant prostate cancer is defined as Gleason 7 and above

IPSS questioner is a validated tool to assess urinary symptoms. Total score is ranged 0-35. Lower values represent a better outcome.

IPSS will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedure

IIEF-5 questioner is a validated tool to assess erectile function in men. Total score is ranged 1-25. Higher values represent a better outcome.

IIEF-5 will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedure

Rabin Medical Center

Central Nervous System Depressants

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Anesthetics

Diuretics

Liver Extracts

Pancrelipase

Pancreatin

Men randomized to the experimental arms will be offered focal treatment of prostate cancer with IRE technology. IRE stands for "irreversible electroporation" and involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death.

Men eligible for radical prostatectomy and randomized to the control arm will undergo radical prostatectomy in line with national guidelines.

Men eligible for radiation therapy and randomized to the control arm will undergo radiation therapy in line with national guidelines.

IRE involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death. The technique is used in Sweden today in radical ablative therapies in the treatment of tumors in the liver, kidney and pancreas. Prior to treatment a Foley catheter is placed. During the treatment, which takes place under anesthesia, the patient is placed in gynecological position and the tumour lesion is located with BK transrectal fusion ultrasound. Thereafter the needles are placed transperineal around the tumor in the prostate using a brachytherapy grid (17Ga Civco brachytherapy grid), guided by the ultrasound/MRI fusion images. Through the needles electrical pulses are then sent to treat the tumor in the center using the Nanoknife technique. After treatment patients are treated with diuretics to flush the kidneys post treatment.

Irreversible electroporation, IRE

Radical prostatectomy

Radiation therapy

Anna Lantz, Ass Prof

Olof Akre, Prof

Anna Lantz, MD PhD

The aim of this study is to evaluate the feasibility to treat localized prostate cancer diagnosed with MRI and targeted/systematic biopsies, with IRE in comparison with conventional radical treatments with the primary objective to locally control the tumour with a minimum of side effects.

OBJECTIVES The aim of the proposed research is to evaluate the cancer control, genitourinary, rectal and overall health-related quality of life outcomes of focal therapy for unifocal localized prostate cancer using irreversible electroporation (IRE).

PRIMARY AIM

• To evaluate functional outcomes in men treated for unifocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy

SECONDARY AIMS

* To evaluate adverse events in men treated for unilfocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy
* To evaluate progression free and treatment free survival in men treated for unifocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy
* Economic evaluation of each technique

TRIAL DESIGN This study is a randomized controlled exploratory trial comparing focal therapy to conventional radical treatment of prostate cancer with the primary aim to evaluate functional outcomes 12 months after treatment.

Patients will be included from 4 different hospitals within the Stockholm County; Karolinska University Hospital, Danderyd Hospital, St Görans Hospital, Södersjukhuset. Eligible patients, after MRI and targeted/systematic biopsies, will be men with clinically significant intermediate-risk PCa or dominant unifocal clinically significant intermediate-risk and small contralateral low-risk disease without previous history of prostate cancer treatment.

Potential study participants will have a visit scheduled together with an urologist and oncologist, where a treatment decision of radical prostatectomy or radiation therapy will be done together with the patient. At this visit the patient will receive oral and written information about the study. If the patient is interested in participating, a baseline visit is scheduled during which informed consent is obtained and the patient randomized to one of two standard treatments or focal treatment.

Patients eligible for radical prostatectomy will be randomized in study 1 to focal treatment or radical prostatectomy. Patients eligible for radiation therapy will be randomized in study 2 to focal treatment or radiation therapy. Time between randomization and treatment will be \<= 6 weeks.

Patients will be asked to fill out study specific questionnaires with questions on functional outcomes and quality of life.

Main outcome measurement in study 1 will be urinary incontinence at 12 months post treatment and in study 2 irritative urinary symptoms 12 months post treatment. Further outcomes will be erectile dysfunction, adverse events, progression-free and treatment-free survival.

Prostate Cancer IRE Study (PRIS)

Prostate Cancer IRE Study (PRIS) - A Randomized Controlled Trial Comparing Focal to Radical Treatment in Localized Prostate Cancer

Urinary incontinence defined by Q3 in EPIC-26, ≥1 pad/day ("Yes") versus none ("No")

Irritative urinary symptoms defined by Q4e in EPIC-26, Moderate/big problem ("Yes") Versus no/small problem ("No")

IIEF score: International Index of Erectile Function, change. The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

International Prostate Symptom Score (IPSS score), change. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

Expanded Prostate Cancer Index, EPIC-26, Q6 change in score. The EPIC-26 is a validated instrument that measures health-related quality of life across 5 PCa-specific domains. Consequently, the minimum symptom score (best HRQOL) = 0 and the maximum symptom score (worst HRQOL) = 12 in each domain. For consistency, the values assigned to each question range from 0 (best) to 4 (worst) regardless of whether there were 4 or 5 response options per question.

EQ5D; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

1. Need for additional focal or whole gland treatment or ADT
2. Need for whole gland treatment or ADT
3. Need for whole gland treatment or ADT or ISUP 2 at 12 mo biopsy

Post-operative PSA ≥0.2 ng/ml or adjuvant treatments including ADT

PSA \>2 over nadir (Phoenix) or adjuvant treatments including ADT

Karolinska University Hospital

Karolinska Institutet

MD PhD Principal Investigator Associate Professor

Rare Diseases

Uterine Cervical Dysplasia

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure

Focal treatment

Karen Smith-McCune, MD, PhD

This is a pilot cohort study of women undergoing focal ablation for high-grade cervical intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics. The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting inclusion criteria were recruited for enrollment into the pilot study of focal treatment. Upon enrollment, they underwent focal ablational treatment rather than standard ablational treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be calculated.

Focal Ablation of Cervical Precancer

Focal Ablation of High-grade Cervical Intraepithelial Neoplasia

Participants will be asked to report any adverse events following focal treatment. These events will be graded according to standard criteria (DAIDS).

Participants will be asked to respond to a survey at enrollment and follow-up asking whether they are satisfied with focal treatment as an alternative method of treatment.

Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.

University of California, San Francisco

high-intensity focused ultrasound, HIFU

Sven Löffeler, MD, PhD

Sven Löffeler

PSA (Prostate-specific antigen) testing has significantly increased the number of men diagnosed with prostate cancer (PCa) and especially patients with low and intermediate risk disease. The effect of radical treatment (treatment of the entire prostate gland) in these risk groups is disputable while the risk of adverse effects, with erectile dysfunction and urinary incontinence, is not. Active surveillance (AS) has been developed as an alternative to radical treatment with the aim of avoiding or delaying radical treatment by closely monitoring for signs of tumor progression. Active surveillance is regarded as the treatment of choice for low-risk prostate cancer. Focal therapy may have a crucial role in improving active surveillance protocols for patients with intermediate localized prostate cancer. Focal eradication of the index-tumor may delay or avoid indefinitely radical treatment for this patient group while significantly reducing treatment-related side effects. Improved MRI-diagnostics and MRI/ ultrasound fusion technology have optimized tumor mapping and classification and this in turn has made partial treatment of the prostate a feasible treatment option.

This study is a prospective cohort study. Patients with intermediate (high-risk) localized PCa and a visible index tumor will be treated with high-intensity focused ultrasound (HIFU).

The aim of the study is to show that there is a significant effect of focal treatment on surveillance biopsies and a reduced conversion to radical treatment, without compromising survival outcomes compared to historical controls (retrospective cohort). A cohort from the more than 450 patients included in the local AS-protocol with MRI at Vestfold hospital trust since 2009 will serve as controls.

1 Needs description It is unclear if eradication with focal treatment of the index-tumor of patients with intermediate-risk prostate cancer followed by active surveillance can reduce the need for radical, whole-gland treatment of the prostate and thereby treatment side effects. It is important for urologists and patients to know if focal treatment of prostate cancer is both a safe and effective treatment option. If proven so, focal treatment of prostate cancer can be offered as a viable, intermediate treatment option for a large group of patients who currently only have the choice between either surveillance or radical treatment.

Thus, there is an unmet need to document the outcome of focal treatment in selected patients with prostate cancer, both in terms of efficacy and safety

2. Hypotheses, aims and objectives

2.1 Hypothesis: Focal treatment of biopsy-verified, localized, MRI-visible, intermediate-risk (and high-risk fo elderly patients) prostate cancer is a safe and effective treatment option. Side effects following focal treatment are transient and mild compared to established and well-documented radical treatment options.

2.2 Aims of the study: To investigate if focal treatment of localized prostate cancer followed by MRI-supplemented active surveillance conveys sufficient tumor control to enable patients to continue indefinitely in this follow-up protocol without the need to convert to radical treatment, with none or mild side effects and without compromising oncological outcomes.

2.3 Objectives:

Primary objectives:

* Eradication of the signal tumor (\<20% positive biopsies in the treated area after one year)
* Low conversion rates to radical treatment (\<20%)
* Good long-term oncological results (\<5% metastasis and \<1% prostate cancer deaths at 10 years)
* Good functional results (\<10% of patients with long-term side effects on erectile function and continence)

Secondary objectives:

* Evaluation of the ability of MRI to predict biopsy results during follow-up.
* Health-related quality of life

  3. Methodology

This study is a prospective, single-arm, case-control cohort study with consecutive patients with intermediate-risk, MRI-visible prostate cancer treated focally with HIFU. Participants will be compared to historical controls (patients observed with AS at SiV 2009-2017). The study design follows the international multidisciplinary consensus on trial design for focal therapy in PCa (28, 29). Patients will primarily be recruited from Vestfold-Telemark County but recruitment from other institutions in Norway is encouraged. More formal referral arrangements will be sought with Aleris (Oslo), Telemark Hospital Trust and Vestre Viken Hospital Trust.

3.1 Project arrangements, method selection and analyses From a scientific and methodological point of view a randomized, parallel-group study would have been preferable with patients receiving either AS+ (HIFU) or simple AS follow-up. However, experience from several investigative centers have shown that randomization is difficult to carry out in practice. This is because patients are aware of the HIFU possibility, and, if randomized to standard treatment, often refuse participation and demand HIFU treatment. This problem would likely be exacerbated in this study, where the control group would be offered only follow-up while study arm patients receive tumor-directed treatment with presumed few side-effects. Furthermore, the investigators have learned from own historic controls that AS is "good medicine" for merely half of the patients with intermediate-risk prostate cancer after 5 years. Since it is difficult, based on today's diagnostic tools, to identify patients that will not progress significantly over time, some form of tumor-directed treatment for all patients is sensible. Finally, patients in the historical control group were diagnosed and risk-classified by the same parameters and diagnostic tools that are currently in use. Follow-up of these patients was also very similar to the one outlined for the study patients. The investigators are not aware of any significant change in clinical practice that would suggest that the historical controls at the study institution are not representative of current patients with intermediate risk profile.

Patients who are interested in focal treatment of prostate cancer are aware of the radical treatment alternatives but are skeptical of the side effects. These patients want to know their risk of progression (metastasis and death), the risk of having to undergo radical treatment at a later stage and the short-term and long-term side effects if they choose focal treatment. We believe that this study will provide these answers for a representative Norwegian patient population.

Based on these considerations, the investigators believe that the best and most ethical design is the one proposed here, where all eligible patients receive the same treatment and are then compared to a historical control group.

Study population and Power-estimate Approximately half of active surveillance patients (50%) experience progression of their disease during 5-10 years follow-up (9). This correlates with the outcome of historical AS patients at the study institution.

The investigators estimate that only 20% of the newly diagnosed AS patients receiving HIFU will experience a progression of their disease after 10 years.

In order to detect such a reduction in progression rate, the trial will need to include 194 patients. With 20% expected dropouts, the number of patients needed to include in the HIFU cohort will be 245.

The sample size calculations are based on the ClinCalc program (http://clincalc.com/stats/samplesize.aspx).

prospective, single-arm, case-control cohort study with consecutive patients with intermediate-risk, MRI-visible prostate cancer treated focally with HIFU. Study patients will be compared to historical controls (patients observed with AS at SiV 2009-2017).

Active Surveillance Plus (AS+): High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer

Active Surveillance Plus (AS+): Local Tumor Control With High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer

Absence of clinically significant prostate cancer (Gleason grade ≥7A) on post-treatment systematic and targeted biopsies

erectile function, continence, and other therapy-related complications. Questionnaire-based.

based on repeated MRI and repeat biopsies performed on clinical/ radiological suspicion

Survey-based using standard questionaires

The Hospital of Vestfold

Principal Investigator

Micro-wave ablation of index lesion identified on MRi on prostate cancer

Micro-wave ablation

Alexandre Peltier, MD

With the advent of multiparametric MRI (mpMRI), the concept of focal therapy continues to develop as a compromise between active surveillance and radical tratment. However, it must be combined with the most stringent quality control measures, such as exceptional Imaging, to allow close management of the index tumor. the choice of the energy is also crucial. Several have been tested such as HIFU, electroporation or cryotherapy. A new therapeutic alternative currently Under investigation resides in the use of microwaves delivered through a thin needle inserted precisely into the index lesion according to the same procedure as targeted biopsy under image fusion to induce coagulation necrosis and lead to the tumor destruction. Through an ablate, performed transrectally under real-time MRI/TRUS image registration and 3D mapping, in patients with localized prostate cancer (PCa).

Patients with a detectable index lesion on mpMRI, PSA level \<20 ng/mL and wishing to undergo a prostatectomy due to significant PCa on biopsy are elibible for this study approved by the Ethics Committee. Targeted biopsies of the index lesion are performed by using an ultrasound-MRI image fusion system with Organ based Tracking (OBT)-registration (Trinity\*, KOELIS, France) to provide quality control. Targeted cores are analyzed intraoperatively with an extemporaneoux analyses. If positive, a targeted focal microwave ablation is achieved during the same session by a single 18G needle inserted transrectally Under sedation. Predictive ablation charts obtained with the 2.45 GHZ frequency microwave generator (TATO, Biomedical Srl, Italy) through ex vivo experiments were used to choose the duration and power of the treatment.

Treated patients are followed-up for 4 to 6 weeks and the planned radical prostatectomy is performed. All treated patients complete uroflowmetry test and questionnaires (IPSS, IPSS-QQL, IIEF-5, and MSHW-EJD-SF) befor, at 7 days and 1 month after the procedure. A mpMRI of the treated prostate is performed at 7 days after the ablation to identify the devascularized area, but also to verify that no organ at risk is affected by the microweve treatment. After radical prostatectomy, whole-mount histology serves to define the ablation boundaries and dimension in the prostate. It also allows to determine the impact of the use of microwaves on cancerous tissue. A total of 10 patients will be enrolled.

Micro-wave Ablation Under Organ-based Tracking in Patients With Prostate Cancer - FOSTINE

Etude de faisabilité de de tolérance d'un Traitement Focal Transrectal Par Micro-ondes de la Tumeur Index Des Patients Ayant un Cancer de la Prostate - FOSTINE 1b

anonymising patients personal data for publications

Tolerance and faisability of transerectal micro wave ablation of index lesion in prostate cancer.

MRI to identify the devascularized area at one week and ablation boundaries and dimensions in the prostate specimen after prostatectomy at one month.

Koelis

Jules Bordet Institute

Curative targeted focal brachytherapy treatment for localized unifocal prostate-cancer

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.

Focal Brachytherapy

Lars Boesen, MD,PhD,DMSci

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.

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

Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source - The Introduction of Prostate Cancer Targeted Focal Therapy Treatment in Denmark

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).

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.

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.

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.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy	NCT03982706	Prostate Cancer		18 Years - 90 Years	Rabin Medical Center
Prostate Cancer IRE Study (PRIS)	NCT05513443	Prostate Cancer	Irreversible el... Radical prostat... Radiation thera...	40 Years -	Karolinska Institutet
Focal Ablation of Cervical Precancer	NCT01709773	High-grade Cerv...	Focal treatment	21 Years - 45 Years	University of California, San Francisco
Active Surveillance Plus (AS+): High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer	NCT04549688	Prostate Cancer	high-intensity ...	18 Years - 80 Years	The Hospital of Vestfold
Micro-wave Ablation Under Organ-based Tracking in Patients With Prostate Cancer - FOSTINE	NCT04831905	Focal Treatment...	Micro-wave abla...	45 Years - 76 Years	Jules Bordet Institute
Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source	NCT06080113	Prostate Cancer	Focal Brachythe...	18 Years - 80 Years	Herlev Hospital
Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source	NCT06080113	Prostate Cancer	Focal Brachythe...	18 Years - 80 Years	Herlev Hospital
Prostate Cancer IRE Study (PRIS)	NCT05513443	Prostate Cancer	Irreversible el... Radical prostat... Radiation thera...	40 Years -	Karolinska Institutet
Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy	NCT03982706	Prostate Cancer		18 Years - 90 Years	Rabin Medical Center

Spots Global Cancer Trial Database for focal treatment