Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Carcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Low Dose Rate (LDR) brachytherapy with I-125 to a total dose of 144 Gy

High Dose Rate brachytherapy: 27 Gy in 2 fractions

Low dose rate brachytherapy

High dose rate brachytherapy

Wendy Parulekar

Alain Haddad

Gerard Morton

Srinivas Raman

Maroie Barkati

M. Tamim Niazi

Eric Vigneault

The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy chosen for this study as well as a commonly used alternate form of brachytherapy called low dose rate (or seed) brachytherapy. Investigators would like to understand how these treatments control the prostate cancer and look at their short and long term treatment related side effects.

The dose of radiation for HDR brachytherapy for this study has been changed since the study started. Other studies using the dose of radiation for HDR brachytherapy that was originally chosen for this study (Arm 2) found that this dose of radiation may be linked to a greater chance of the cancer coming back in the prostate. Therefore since March 2020, for new participants entering the study, a new HDR brachytherapy arm with a higher amount of radiation given over two doses will be tested in this study

Radiation therapy is an accepted treatment to help manage low and intermediate risk prostate cancer. Radiation therapy can be given using machines that are outside the body (called "image guided external beam radiation therapy") or by brachytherapy, which is a form of radiation therapy where the radiation source is placed directly into the prostate gland near the tumour. The standard or usual treatments for low or intermediate risk prostate cancer are low dose-rate (LDR) brachytherapy which involves placing radioactive seeds in the prostate which deliver radiation over several months, image guided external beam radiation therapy (IGRT), or IGRT plus high dose-rate (HDR) brachytherapy boost.

High Dose-Rate (HDR) brachytherapy is another type of brachytherapy which delivers a high dose of radiation to the tumour over a period of minutes. The radiation is delivered under computer control through flexible needles, which are temporarily inserted into the prostate. This form of radiotherapy targets cancer cells within the prostate gland. HDR brachytherapy is another type of radiotherapy for prostate cancer that has the potential to help target your cancer more accurately while causing fewer side effects compared with standard radiation therapy. HDR brachytherapy is an option for treatment in some hospitals now but the best dose of radiation is still unknown. This study is testing a new dose of radiation for HDR brachytherapy.

Phase II High Dose Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

The primary endpoint of the study is prostate cancer control rate at 48 months. It is defined as the PSA \<0.4ng/ml at 48 months. One sample binomial test will be used to test the 48 months disease control rate for each arm

Acute and long term toxicity and safety including lower urinary tract symptoms

Resource utilization and economic indices of treatment administration

Canadian Cancer Trials Group

Adenocarcinoma

Central Nervous System Depressants

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Anesthetics

Iodine

Cadexomer iodine

External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks

A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient.

A single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate

36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique.

5500 cGy/20 fractions delivered 5 days per week over 4 weeks

Hypofractionated external beam radiotherapy

A single fraction of 19 Gy is delivered from an automated afterloading Iridium-192 source via interstitial catheters placed under ultrasound guidance

Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance

Permanent seed implant

External radiation using SABR technology delivers 36.25 Gy to the prostate in 5 fractions given either once weekly for 5 weeks or every second day over 2 weeks.

Stereotactic body radiotherapy

Juanita Crook, MD

Deidre Batchelar, PhD

Cynthia Araujo, PhD

David Kim, MD

David Petrik, MD

Michelle Hilts, PhD

Ross Halperin, MD

Halperin Ross, MD

Winkle Kwan, MD

Mira Keyes, MD

Saibishkumar Elantholi Parmeswaran, MD

Jordan Wong, MD

Jonathan Livergant, MD

Howard Pai, MD

Abe Alexander, MD

We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.

Men newly diagnosed with low volume oligometastatic prostate cancer defined as fewer than 5 bone metastases and/or non regional lymph node involvement who agree to treatment of the primary cancer with radiation will be randomized between standard moderately hypofractionated external radiotherapy (5500 centiGray/20 fractions as per Stampede trial) and one of 3 alternatives: stereotactic body radiotherapy (SABR) to deliver 36 Gy/5 fractions, or low dose rate Iodine 125 permanent seed implant or a single high dose rate temporary implant. The trial will take place in 4 regional cancer centers of British Columbia Cancer Agency, with each center choosing their preferred alternative to 5500/20. To achieve 4 equally sized treatment arms, each randomization is weighted 3:1 for 42 patients in each arm and 168 total accrual. The primary endpoint is urinary quality of life as assessed by the International Prostate Symptom Score (IPSS) . As the typical acute symptoms from each of these radiation modalities has a unique time course, assessments are done at 6 different points during the first 2 years. Secondary endpoints are global quality of life as assessed by Expanded Prostate Cancer Index (EPIC) urinary, bowel and sexual scores, progression free survival, overall survival and cost effectiveness.

There is one standard arm (5500/20) and 3 alternative arms. The alternative arms are center (or investigator) specific. Thus, each randomization is 2-way, but with a 3:1 weighting so that the 4 treatment arms have equal numbers of patients.

5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)

Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment

International Prostate Symptom score (0/35), higher worse

Urinary Quality of life, 0/100 higher score better

Bowel quality of life, 0/100, higher score better. Series of validated questions concerning urgency, frequency, consistency, leakage, presence of blood and pain with bowel movements and then rates how big a problem each symptom was (0-5)

Sexual quality of life, 0/100, higher score better. Series of validated questions concerning frequency and quality of erections, presence of morning erections, ability to engage in sexual activity or intercourse, rates ability and then rates importance of each issue to the patient.

Progression free survival measured as time to Prostate Specific Antigen (PSA) rise by 50% \> nadir

Progression free survival measured as time to new or progressive bone metastases

Progression free survival measured as new or progressive adenopathy on imaging

Overall survival regardless of cause of death

Analysis of primary treatment costs and secondary treatment costs at time of progression

British Columbia Cancer Agency

Professor of Radiation Oncology

Other Dietary Supplements

Benzocaine

Tannic Acid

An array of 17 gauge steel needles, 20 cm in length, is inserted under Ultrasound (US) guidance into the prostate and advanced to the base of the prostate. A template is used to maintain spacing and parallelism and the needles are individually locked into the template once positioned. A continuously acquired set of US images is obtained for treatment planning purposes. Each needle is connected to a Varisource afterloader and treatment is delivered using a 10 Curie Iridium-192 source. The needles are then removed.

HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy

HDR prostate brachytherapy

Matthew Schmid, MSc

High Dose Rate (HDR) temporary prostate brachytherapy offers a precise form of dose escalation for prostate cancer. Needles are placed, the position is confirmed and treatment is delivered. Previously High Dose Rate prostate brachytherapy was performed under TransRectal UltraSound (TRUS) guidance but planned with Computed Tomography (CT) imaging which introduced a source of error through needle displacement while transporting and repositioning patient. Recently Varian has introduced a one-step procedure where both implant and planning are based on UltraSound imaging and performed without patient repositioning. This planning system is approved by Health Canada and is commercially available.

This study will use High Dose Rate brachytherapy to treat 20 men. Treatment will be planned with TransRectal UltraSound and validated using Computed Tomography imaging.

Twenty men with intermediate risk prostate cancer, suitable for the combination of external beam radiotherapy and High Dose Rate brachytherapy will be entered in this study. High Dose Rate brachytherapy will be performed using TransRectal UltraSound guidance and then planned using both cone-beam Computed Tomography and TransRectal UltraSound. Planning by Computed Tomography is to check the reliability and reproducibility of UltraSound imaging to correctly identify the needle positions. Correct needle localization is essential because this is the basis for determining source dwell positions, dose calculation and dose optimization.

CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse

High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm

Precise location of the tip of each needle in 3-dimensional space relative to the prostate determines the pattern of dose delivery. Inaccuracies in needle tip location may lead to differences detected between UltraSound(US)-based and Computed Tomography (CT)-based plans.The distance of the needle tip (as identified on either CT images or US images) protruding beyond the template was measured in mm. The template acted as a fixed reference point as it was locked into the stabilizer/stepper apparatus. The 2 protrusion readings for each needle tip were compared, the difference recorded in mm, and categorized as \< 1 mm, 1-2 mm, 2-3 mm and \> 3 mm.

MD FRCPC

Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy.

Localized Prostate Cancer

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Canada

Region of Enrollment

Dr Juanita Crook

Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography

HDR prostate brachytherapy: HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy

HDR Prostate Brachytherapy

Overall Study

Symptoms and General Pathology

Recurrence

High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT

Simon Buus, MD

Simon Buus

The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

The aim of this study is to examine the efficacy and toxicity of focal salvage high dose rate brachytherapy (HDR BT) for patients with locally recurrent prostate cancer after definitive external beam radiotherapy. Furthermore, the investigators want to assess, whether it is feasible to perform salvage HDR BT as a focal treatment based on multiparametric (mp) pelvine MRI and PSMA PET/CT.

Salvage HDR for Locally Recurrent Prostate Cancer

Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial

The time from intervention until the prostate cancer becomes castration resistant

Erectile dysfunction as reported by patients in CTCAE PRO

Urinary symptoms as reported by patients in CTCAE PRO

Bowel symptoms as reported by patients in CTCAE PRO

Aarhus University Hospital

Principal investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Breast Diseases

Skin Diseases

Accelerated Partial Breast Irradiation with multicatheter brachytherapy

Standard External Beam Whole Breast Irradiation

Accelerated partial breast irradiation

External beam whole breast irradiation

Vratislav Strnad, MD

Csaba Polgár, MD

Oliver J Ott, MD

To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer

Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-risk Invasive Carcinoma and Low-risk Ductal Carcinoma in Situ (DCIS) of the Female Breast

University of Erlangen-Nürnberg Medical School

Behaviors and Mental Disorders

Erectile Dysfunction

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Androgens

After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 \< 110% , rectum D2cc\<75% (below 75Gy EQD2).

Before SBRT three fiducial markers are obligatory inserted into the prostate.Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy \<5 cm³ for bladder, V 20 Gy \<10 cm³ for femoral heads. Androgen deprivation therapy is not permitted.

All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional.

Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate).

Stereotactic ablative radiotherapy

Sergey Novikov

This is single center prospective phase 2 randomized trial aiming to compare biochemical and clinical relapse free survival and toxicity profiles of stereotactic body radiotherapy (SBRT) versus high dose rate brachytherapy (HDRB) for localized low- and intermediate risk prostate cancer patients.

Before SBRT three fiducial markers are obligatory inserted into the prostate. Simulation and every SBRT sessions are performed after bowel preparation (enema) and bladder filling (400ml).Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. The clinical target volume (CTV) include the prostate only (low-risk patients) or prostate and proximal 1/3 of seminal vesicles (intermediate-risk patients). CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy \<5 cm³ for bladder, V 20 Gy \<10 cm³ for femoral heads. Androgen deprivation therapy is not permitted.

All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional.

After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 \< 110% , rectum D2cc\<75% (below 75Gy EQD2).

Patients are assessed during treatment, 4-12 weeks after the end of the treatment, every 3 months for the first year and then every 6 months till the end of the study. Normal tissue adverse events are reported according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0). International prostate symptoms score (IPSS) and international index of erectile function (IIEF-5) must be assessed on each visit, maximal urinary rate and residual urine volume - annually.

Prostate cancer can be detected only in male patients

HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer

High Dose Rate Brachytherapy vs Stereotactic Ablative Body Therapy in Patients With Early-intermediate Prostate Cancer

To evaluate frequency of grade 3-5 toxicity in patients treated by high dose rate brachutherapy (arm 1) and stereotactic ablative radiotherapy (arm 2)

Assessed by International Index of Erectile Function (IIEF)

PSA levels in the blood. Reccurence - nadir + 2 ng/ml

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II High Dose Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer	NCT02960087	Prostate Carcin...	Low dose rate b... High dose rate ...	18 Years -	Canadian Cancer Trials Group
5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)	NCT04610372	Oligometastatic...	Hypofractionate... High dose rate ... Permanent seed ... Stereotactic bo...	18 Years -	British Columbia Cancer Agency
CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse	NCT01248741	Prostate Cancer Interstitial Ra... High Dose Rate ... Ultrasound-base...	HDR prostate br...	45 Years - 80 Years	British Columbia Cancer Agency
Salvage HDR for Locally Recurrent Prostate Cancer	NCT04231006	Prostate Cancer	High dose rate ...	18 Years -	Aarhus University Hospital
APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer	NCT00402519	Breast Cancer	Accelerated par... External beam w...	40 Years -	University of Erlangen-Nürnberg Medical School
HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer	NCT04870567	Biochemical Rel... Complications R...	Stereotactic ab... High dose rate ...	18 Years - 90 Years	N.N. Petrov National Medical Research Center of Oncology
Salvage HDR for Locally Recurrent Prostate Cancer	NCT04231006	Prostate Cancer	High dose rate ...	18 Years -	Aarhus University Hospital
HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer	NCT04870567	Biochemical Rel... Complications R...	Stereotactic ab... High dose rate ...	18 Years - 90 Years	N.N. Petrov National Medical Research Center of Oncology
HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer	NCT04870567	Biochemical Rel... Complications R...	Stereotactic ab... High dose rate ...	18 Years - 90 Years	N.N. Petrov National Medical Research Center of Oncology

Spots Global Cancer Trial Database for high dose rate brachytherapy