Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stereotactic Ablative Radiation 26 Gy in 2 fractions, once weekly to prostate

Stereotactic Ablative Radiation

Andrew A Loblaw

You have been asked to consider participating in the study because you have a cancer of the prostate, which is to be treated with external beam radiation. You have chosen or felt not to be a good candidate for just watching your cancer. As your doctor has informed you, this involves delivering small amounts of radiation daily over several weeks. Normally, a small field directed to the prostate gland is given for 7.5 - 8 weeks. In total, 39 days of radiation are delivered. There is now growing evidence that prostate cancer cells may be killed more effectively if higher doses of radiation are delivered everyday (known as hypofractionation). However, the downside to such a strategy is the potential to cause more side effects because normal organs (such as the rectum and bladder) are also exposed to the higher doses. Stereotactic ablative radiotherapy (SABR) is a high-precision technique which has the ability to deliver radiation in a more focused manor, meaning that the radiation dose can be "sculpted" to the prostate gland, while minimizing the amount of radiation to the bladder and rectum.

A certain amount of movement of the prostate normally occurs within the body. To make sure that the prostate will not be missed, a margin of tissue around the prostate also needs to be treated. Although a wide margin will ensure that the prostate is included, it will also cause more normal tissue to receive high doses of radiation. This, in turn, would result in more side effects. To reduce the margin needed around the prostate, and side effects, tiny gold seeds measuring 3.0 x 1.2mm will be inserted into the prostate which can be seen using a special type of X-Ray camera called a portal imager during treatment. This will allow for targeting of the prostate gland more precisely so that a significantly smaller margin of normal tissue will need to be treated. By using gold seeds in conjunction with SABR, there is the potential to safely deliver a more intensive dose of radiation to the prostate gland without increasing the amount of side effects.

In other studies where shorter and more intense courses of radiation have been given using similar high-precision techniques, the side effects of treatment have indeed been no worse than the usual techniques. Over the last 7 years, Sunnybrook researchers have treated over three hundred prostate cancer patients on various research protocols with SABR. In those protocols, patients received 5 SBRT treatments over 29 days and this is currently being compared to 5 SBRT treatments over 11 days in an ongoing randomized study. In the United States, several groups have investigated the 5 SBRT approach in 11 days or less and early findings suggest a good tolerance.

The study is being done to determine the side effects, quality of life and efficacy of 2-fraction adaptive SBRT technique (2STAR) in the treatment of low and intermediate risk prostate cancer. All participants will receive the same dose and fractionation scheme.

Two StereoTactic Ablative Adaptive Radiotherapy Treatments for Localized Prostate Cancer

To determine the prostate-specific quality of life (QOL) using the Expanded Prostate Cancer Index Composite (EPIC) 37 questionnaire for patients undergoing a 2 fraction SBRT protocol. QOL using the Expanded Prostate Cancer Index Composite (EPIC) will be obtained at baseline, weeks 1, 4, 12, month 6 and every 6 months until year 5.

Sunnybrook Health Sciences Centre

Radiation Oncologist

Symptoms and General Pathology

Disease Progression

All Drugs and Chemicals

Immunomodulating Agents

PD-L1 assessment on biopsy of metastatic site (biopsy will be performed if no prior metastasis sample available)

A stereotactic relocalization system that relies upon stereoscopic radiographs, implanted fiducials, or near real-time CT based verification will be used.Investigators will have the discretion to choose from biologically equivalent dose levels using 1, 3 or 5 fractions. All active lesions need to be addressed by local therapy

Aurelie Garant

To evaluate the benefit of SAbR for oligo-progressive metastatic urothelial cancer.

Oligo-progressive urothelial cancer with limited disease burden and progression on an anti-PD-1/L1 immune checkpoint inhibitor.

Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer

A Phase II Trial of Stereotactic Ablative Radiation (SAbR) for Urothelial Cancer Patients With Progression While on Anti-PD-1/PD-L1 Immunotherapy

Progression free survival (PFS) at 6 months in the patients for whom SAbR is added to the ICI after progression on ICI. PFS will be defined as the combination of progressive disease from SAbR start date and death from any cause.

The disease control rate in patients for whom SAbR is added to ICI after progression on ICI. DCR will be assessed per RECIST 1.1 criteria and defined as the combination of: Complete Response (CR), Partial Response (PR), or Stable Disease (SD).

The time to initiation of next-line systemic therapy following the addition of SAbR to ICI after progression on ICI.

The overall survival of patients since progression on ICI or at the study registration. Overall survival (OS) will be defined using the interval between enrollment and death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Two StereoTactic Ablative Adaptive Radiotherapy Treatments for Localized Prostate Cancer	NCT02031328	Prostate Adenoc...	Stereotactic Ab...	18 Years -	Sunnybrook Health Sciences Centre
Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer	NCT04131634	Urothelial Canc...	Stereotactic Ab...	18 Years -	University of Texas Southwestern Medical Center
Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer	NCT04131634	Urothelial Canc...	Stereotactic Ab...	18 Years -	University of Texas Southwestern Medical Center
Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer	NCT04131634	Urothelial Canc...	Stereotactic Ab...	18 Years -	University of Texas Southwestern Medical Center
Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer	NCT04131634	Urothelial Canc...	Stereotactic Ab...	18 Years -	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for stereotactic ablative radiation