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

HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy

HDR-Brachytherapy

Vratislab Strnad, MD

Vratislav Strnad, MD

Bastian Keck, MD

Alexander Cavallaro, MD

Arndt Hartmann, MD

Michael Lotter, Dipl.-Phys.

Annedore Strnad, MD, MHBA

Peter Goebell, MD

Wolfgang Uter, MD

Michael Uder, MD

Bernd Wullich, MD

Rainer Fietkau, MD

This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.

Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.

Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial

University of Erlangen-Nürnberg Medical School

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.

Herlev Hospital

MD, PhD, DMSci, Associate Professor

Behaviors and Mental Disorders

Quality of Life

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.

A re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions. Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment. The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125). The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment.

Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

Michael Zelefsky, MD

The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer. The study is also looking at how useful focal brachytherapy will be in treating prostate cancer. Additionally, the investigators would like to see how this type of treatment impacts quality of life.

Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer

Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer

focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered. "All negative" means no prostate cancer;

Following focal brachytherapy in patients with early stage low volume localized prostate cancer. The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ

Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined. Post-treatment biopsy outcome is defined as a binary variable: positive and negative. We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy. The correlation will be assessed by a Fisher exact test.

University of Colorado, Denver

M.D. Anderson Cancer Center

Northwell Health

Memorial Sloan Kettering Cancer Center

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Michael Zelefsky, MD

To Assess the Late Toxicity Outcomes

To Evaluate the Local Tumor Control After Focal Brachytherapy

To Evaluate the Change From Baseline in QOL Indicators

To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes

Overall Study

Focal brachytherapy with permanent I125 localized implant.

Focal brachytherapy

This is a pilot prospective biomedical study of interventional type which includes 17 patients on 24 months (12 months of inclusion and 12 months of follow-up).

The objective of this study is to verify that the focal therapy technique used (with the help of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days after implantation.

Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.

Feasibility of focal therapy will be evaluated in terms of "success" or "failure" : success will be obtained in case of delivered dose of at least 152 Gy on the 1st dose enveloping the Planning Target Volume, evaluated on CT scan/MRI performed at Day 30

Progression-free-survival is defined as the time from patient inclusion to the date of biological progression according to Phoenix criterion

Quality of life will be evaluated using 3 Patient questionnaires : the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire, the International Index of Erectile Function Questionnaire and the International Prostate Symptom Score Questionnaire

The absence of tumor residuals in the target treated zone will be evaluated on on biopsies performed 1 year after implantation

Toxicity will be evaluated according to the classification of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial	NCT02391051	Prostate Cancer	HDR-Brachythera...	18 Years -	University of Erlangen-Nürnberg Medical School
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
Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer	NCT01354951	Prostate Cancer	Prostate Biopsy...	21 Years -	Memorial Sloan Kettering Cancer Center
Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.	NCT01902680	Localized Prost...	Focal brachythe...	18 Years -	Institut Claudius Regaud
Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.	NCT01902680	Localized Prost...	Focal brachythe...	18 Years -	Institut Claudius Regaud

Spots Global Cancer Trial Database for focal brachytherapy