Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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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

Symptoms and General Pathology

Recurrence

Brachytherapy will be administered using the CivaSheet, a novel permanent LDR palladium-103 (Pd-103) planar brachytherapy device that is applied directly to the surgical resection bed.

CivaSheet

Brachytherapy

surgical resection

Abraham Wu, MD

This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy (IORT) device that offers several advantages over existing techniques of performing IORT. The CivaSheet device in this study is already approved by the FDA and is not an experimental device. This study will allow us to determine how feasible it is to implant the CivaSheet into patients undergoing surgery for abdominal and pelvic tumors, and assess any possible side effects of the device. This study, if successful, may allow us to offer the CivaSheet more widely as treatment option to future patients.

Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet

A Pilot Feasibility Trial of Unidirectional Low Dose Rate Brachytherapy for Patients With Abdominal and Pelvic Malignancy Undergoing Surgical Resection Requiring Intraoperative Radiation Therapy

Feasibility is determined by successful implantation of the device into a patient who has been enrolled on the protocol and deemed appropriate for IORT at the time of surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet	NCT02902107	Abdominal Malig... Pelvic Malignan...	CivaSheet Brachytherapy surgical resect...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for low dose rate brachytherapy