stereotactic body radiotherapy (SBRT) for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sunnybrook Cancer center, Toronto, Canada
Prostate Cancer+1 More
stereotactic body radiotherapy (SBRT) - Radiation
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a new radiation treatment called stereotactic body radiation therapy (SBRT) is safe and effective for treating prostate cancer.

See full description

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Study Objectives

This trial is evaluating whether stereotactic body radiotherapy (SBRT) will improve 1 primary outcome and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 6.5 years.

6.5 years
Biochemical disease-free survival
Early Adverse Events/toxicities experience by Participants
Late Adverse Events/toxicities experienced by Participants
Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire
6.5years
Health Utilities using EuroQol- 5 Dimension Questionnaire
Health Utilities using The Patient-Oriented Prostate Utility Scale

Trial Safety

Trial Design

1 Treatment Group

Men with prostate cancer post-prostatectomy
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Stereotactic Body Radiotherapy (SBRT) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Men with prostate cancer post-prostatectomy
Radiation
Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6.5years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6.5years for reporting.

Who is running the study

Principal Investigator
C. (. T.
Prof. Chia-Lin (Eric) Tseng, Principal Investigator, Assistant Professor, Dept of Radiation Oncology Sunnybrook Odette Cancer Centre
Sunnybrook Health Sciences Centre

Closest Location

Sunnybrook Cancer center - Toronto, Canada

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy
Completed written informed consent
Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires
A detectable PSA ≤ 2.0 ng/ml
Two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three or more consecutive rises in PSA

Patient Q&A Section

What is prostate cancer?

"Prostate cancer is a disorder involving malignant tumour formation or malignant proliferation in the peripheral tissues (mucosa or prostatic epithelium) of the prostate gland. Patients are generally diagnosed in their 50s or early 60s and have a very poor outcome, even after radical prostatectomy. It is estimated that in the USA, 21,500 new cases were diagnosed in 2012, making it the eighth most common cancer (after breast, prostate, colorectal, lung, stomach, melanoma and cervical) in this cohort. The global burden of disease for a new prostate cancer diagnosis has been estimated as 14.1 million disability adjusted life years (DALYs)." - Anonymous Online Contributor

Unverified Answer

How many people get prostate cancer a year in the United States?

"More than 250,000 cases of prostate cancer are diagnosed each year in the United States. Men at high risk for prostate cancer can be identified on the basis of self-report and age." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"More than half (57%) of Americans reported receiving treatment for prostate cancer within the last 12 months. However, only 36% of men reported knowing the side effects or potential risks of the treatment. The reasons for not receiving treatment may be a lack of perceived need, difficulty paying for treatment, limited access to treatment and lack of awareness regarding treatment." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"Current treatment options for prostate cancer include radical prostatic surgery, external beam radiation therapy, and hormone therapy, which may offer symptomatic improvement in half or less than 50% of men. However, these treatments do not provide cure. In the absence of an effective cure for prostate cancer, it would be the only disease in which total remission from symptoms was achieved." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"The genetic and environmental factors are thought to be responsible in a large proportion of cases. Genetic and environmental factors are probably not to blame for a small proportion of cases." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"Symptoms affecting the prostate may include persistent and frequent, painful, or bloody urination, loss of bladder control, or sudden pain or swelling of the penis. Symptoms suggestive of the presence of cancer include persistent headaches or difficulty swallowing, fever, pain or redness in the groin, urinary tract, testicles or prostate, or weight loss.\n\nA physician should recognize any of the signs and symptom patterns that can indicate a diagnosis of prostate cancer – even if the exact cause of the symptoms is not known or if there is a reasonable alternate explanation.\n\nTreating patients with prostate cancer has a significant impact on health care resources." - Anonymous Online Contributor

Unverified Answer

What is stereotactic body radiotherapy (sbrt)?

"The authors conclude that SBRT provides favorable results in patients with primary or metastatic prostate tumors. In addition, it is particularly useful in localized cases. This therapeutic modality is easily administered postoperatively under a sterile technique. A recent meta-analysis has demonstrated an overall survival benefit for SBRT when compared with watchful waiting or radiation alone in localized prostate cancer. Stereotactic body radiation may prove useful for the management of patients with tumors with unfavorable characteristics, such as in patients with a pelvic lymph node involvement or a T-stage of T2a or greater." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing prostate cancer?

"The chances of developing [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) can be defined from the relative risk of developing prostate cancer (RRR of prostate cancer) and the prostate specific antigen (PSA) value. This estimation assumes a constant overall risk of prostate cancer over time as PSA varies." - Anonymous Online Contributor

Unverified Answer

How does stereotactic body radiotherapy (sbrt) work?

"Results from a recent clinical trial, there was no improvement in the local control compared with IMRT, but the toxicity was significantly less. SBRT may be considered to be a valid non-hormonal treatment option for men with prostate cancer. However, long-term follow-up is required." - Anonymous Online Contributor

Unverified Answer

What is the latest research for prostate cancer?

"A variety of research findings related to PSA testing and prostate cancer were reviewed. The most significant research findings are listed below. Bibliography lists research cited by the authors." - Anonymous Online Contributor

Unverified Answer

How serious can prostate cancer be?

"Prostate cancer has a poor prognosis and a high mortality rate. It is possible to identify the specific clinical signs, the risk factors and the most informative treatment of the prostate cancer for a given risk group. This treatment modality may be applied for localized malignant disease or for the whole body. The severity of the prostate cancer, and the risk of treatment failure and post-therapy complications are based on an estimation of the individual clinicopathological features and the clinical course of the disease." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in stereotactic body radiotherapy (sbrt) for therapeutic use?

"SBRT for prostate cancer is now a standard of care therapy. A more aggressive approach is associated with improved clinical outcomes and reduced acute toxicity compared with IMRT. This approach may be especially advantageous for patients with high-risk disease, and for those who are not candidates for salvage RT or adjuvant RT following BCT. In the future, a dose escalation strategy combined with a more conservative approach may significantly reduce the need for salvage RT or adjuvant RT for the majority of patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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