Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
McGill University Health Centre-Cedars Cancer Centre, Montréal, Canada
Prostate Cancer+1 More
Stereotactic Body Radiation Therapy (SBRT) - Radiation
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a gel can be used to increase the separation between the prostate and rectum, and if this can be done safely.

See full description

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Stereotactic Body Radiation Therapy (SBRT) will improve 2 primary outcomes and 2 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 3 months.

3 months
Bladder complications
Small bowel or rectal irritation
3 years
To assess late GI and GU toxicity
5 years
PSA control

Trial Safety

Side Effects for

Gem + Xeloda + SBRT
Anemia
21%
Neutropenia
18%
Diarrhea
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Liver Dysfunction
12%
Hand-Foot
9%
Bleeding
3%
Edema
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
3%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01360593) in the Gem + Xeloda + SBRT ARM group. Side effects include: Anemia with 21%, Neutropenia with 18%, Diarrhea with 15%, Hypoalbuminemia with 15%, White blood cell decreased ( leukopenia) with 15%.

Trial Design

1 Treatment Group

Single Fraction SBRT in the treatment of prostate cancer
1 of 1
Experimental Treatment

This trial requires 12 total participants across 1 different treatment group

This trial involves a single treatment. Stereotactic Body Radiation Therapy (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.

Single Fraction SBRT in the treatment of prostate cancer
Radiation
Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2014
Completed Phase 2
~630

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

McGill University Health Centre-Cedars Cancer Centre - Montréal, Canada

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No signs of prostate cancer The individual has a low risk for prostate cancer. show original
A prostate tumor that is histologically confirmed to be adenocarcinoma and is either at stage T2b on the American Joint Committee on Cancer (AJCC) 7th edition scale, has a Gleason score of 6 or 7 (3+4) or a Gleason score of 7 (4+3) and a recent prostate-specific antigen (PSA) level of less than 10 (less than 30 days; the PSA level must have been obtained more than 90 days after the person stopped taking dutasteride or more than 30 days after the person stopped taking finasteride). show original
The patient Zubrod Performance Status 0-1 within 60 days prior to registration. show original
Age >: 18
The patient will need to sign an agreement indicating they understand the study and what is involved before they are allowed to take part in the study. show original
If a man's recent prostate-specific antigen (PSA) level is 15 ng/dL or lower (measured within the past 30 days), and if his Gleason score is 7 (4+3), then his PSA level is considered to be low show original

Patient Q&A Section

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

"This analysis suggests that, in 2005, an estimated 1,290,900 men in the United States, or about one-third of all American males, were diagnosed with prostate cancer, representing an average annual incidence rate of 62 cases per 100,000 male population. Among the estimated 1,290,900 men, about 10,800 men died from prostate cancer. This number represents a 4.5% total mortality rate for all causes of death, and approximately 2.7% of the total number of deaths among all U.S. men." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"Most advanced prostate cancers cannot be cured by conventional therapeutic modalities. However, in a minority of patients a limited number of salvage radiation therapies can result in modest tumour control. A cure is not possible in spite of these treatments. Consequently, the term 'cure' ought to be restricted to a control, particularly because of the lack of a 'complete' cure in advanced prostate cancer." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"The disease's prevalence globally in males is 6.2 per 100,000 men, and 10 percent in United States will be diagnosed and diagnosed 1 year after diagnosis. The disease usually starts out in the early 20s. The average life expectancy post diagnosis is a little more than 8 years. The typical time from onset to death is 1 year. The common presenting symptom is bladder problems. One in every four men will also have trouble urinating.\n\nThe disease is more common in Caucasians and Asians. More than half of the world's people have the disease but more than half of those diagnosed have the disease in the west." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"The genetics, environment, lifestyle, and lifestyle choices of men may in part explain how prostate cancer develops. Research is needed to identify men who are at high risk, and then to develop effective preventive measures." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"Pulsed-dose rate brachytherapy for prostate brachytherapy is now a standard treatment, typically in combination with external-beam radiotherapy, hormonal therapy, and/or salvage chemotherapy. Sipuleucel-T may be a viable treatment option for certain prostate cancer patients.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"Symptoms of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) include abnormal bowel or bladder function, recurrent urinary infections, bone pain, and loss of libido. The prostate cancer diagnosis is usually made at an earlier age on signs from the prostate alone than from signs of other cancers. Symptoms of prostate cancer are often not notifiable. Patients should be advised to see a medical oncologist as soon as possible when they present with the symptoms of prostate cancer." - Anonymous Online Contributor

Unverified Answer

How serious can prostate cancer be?

"Prostate cancer is a debilitating disease that deserves serious consideration and proper management. If the disease is detected early, the patient can be treated in a conservative manner avoiding complications. If there is a disease of long duration, even then, with proper treatment and follow ups, patient is less likely to go to hospital because is asymptomatic. However, careful follow up even in asymptomatic patient is still necessary to avoid complications such as urethral strictures and bladder cancer." - Anonymous Online Contributor

Unverified Answer

How does stereotactic body radiation therapy (sbrt) work?

"In the absence of complete tumour volume coverage of surrounding normal tissues, the dosimetric parameters from the initial planning CT may be significantly different from actual treatment-delivered sbrt. Tumour shrinkage, but the lack of complete tumour coverage still may improve the efficacy of sbrt. The initial planning CT should not be the only source of information for sbrt treatment delivery. This is important considering the need for the accuracy in delivering high dose of radiation with no underdoses especially for small tumour volumes, where maximal tumour response is required." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for prostate cancer?

"Because patient characteristics do not always match well among clinical trial groups, clinicians should consider these demographics when initiating clinical trials as a means to optimize patient benefit from trial participation." - Anonymous Online Contributor

Unverified Answer

What is stereotactic body radiation therapy (sbrt)?

"Stereotactic body radiation therapy (sbrt) is an effective treatment for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) that is currently being used less frequently. It is a technique of high-dose, high fraction-rate, high-volume radiotherapy, which delivers a high dose to the tumor and a low dose to normal tissues and organs around the tumor. If necessary, radiosurgery may be used to treat tiny secondary cancers and their metastases that are not amenable to surgical resection or embolization. In clinical practice, the stereotactic technique achieves a cure rate close to that obtained by radical prostatectomy. It yields low rates of toxicity and maintains satisfactory urinary and erectile function." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of prostate cancer?

"It is generally agreed that there are at least four main categories of risk factors that play a leading role in the risk of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer): genetic, environmental, viral, and nutritional. These factors affect the rate of development, the time delay for presentation of disease, and the stage of the disease. However, these categories are not exclusive to prostate cancer. Some cancer can result from numerous risk factors. The combination of these risk factors may also affect the aggressiveness of prostate cancer (which has been called the constellation of disease/risk factors): Genetic factors + Viral factors + Nutrition. As the incidence has grown, disease severity has increased, and mortality rates have increased along with improved early detection and treatment." - Anonymous Online Contributor

Unverified Answer

Does prostate cancer run in families?

"There seems to be a strong genetic component of prostate cancer. The risk of developing prostate cancer appears to increase significantly with a family history of prostate cancer." - 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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