focal salvage HDR prostate brachytherapy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sunnybrook Health Sciences Centre, Odette Cancer Centre, Toronto, Canada
Prostate Cancer+1 More
focal salvage HDR prostate brachytherapy - Radiation
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a treatment for prostate cancer can be done in a less invasive way.

See full description

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether focal salvage HDR prostate brachytherapy will improve 1 primary outcome and 4 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Acute period (<6 months).

5 years
Acute and late urinary toxicities
Biochemical (ie. prostate specific antigen) disease free survival
Quality of Life (QoL)
Acute period (<6 months)
Incidence of acute urinary and rectal toxicities
Late period (>6 months)
Incidence of late urinary and rectal toxicities

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Focal salvage HDR prostate brachytherapy
1 of 1
Experimental Treatment

This trial requires 60 total participants across 1 different treatment group

This trial involves a single treatment. Focal Salvage HDR Prostate Brachytherapy 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.

Focal salvage HDR prostate brachytherapy
Radiation

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.

Who is running the study

Principal Investigator
D. H. C.
Dr. Hans Chung, MD
Sunnybrook Health Sciences Centre

Closest Location

Sunnybrook Health Sciences Centre, Odette Cancer Centre - Toronto, Canada

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Prostate Cancer or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Biopsy-confirmed locally recurrent prostate adenocarcinoma > 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy by a stereotactic transperineal biopsy
Staging T2-weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
American Urological Association Symptom Index Score (ie. IPSS) < 15
Baseline (post-XRT) serum PSA < 10 ng/mL
Prostate volume as measured by transrectal ultrasound (TRUS) < 50cc
ECOG performance status 0-1

Patient Q&A Section

Can prostate cancer be cured?

"In patients who have undergone radical prostatectomy for high-risk prostate cancer, there was a significant but progressive decrease in clinical and PSA progression for up to 8 years according to our results. However, progression was not statistically significant after adjustment for PSA, grade, and stage at time of diagnosis and the treatment received. As most patients who received salvage radiotherapy were progression-free at 6 years, longer postprostatectomy survival might be expected. We propose that patients presenting with high-risk disease should be counselled with radical treatment modalities as the opportunity may be presented at the time of surgery." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"Men with prostate cancer may have increased urinary frequency as a result of bladder outlet obstruction. There may also be signs of the disease in the blood, including erythropoietin or hematological abnormalities. The common occurrence of erythrocytosis and anemia in the prostate cancer population may be a result of blood flow alterations." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"This is a health article of interest. It discusses all of the information to be looked for. These are some of the common questions a person may have and some of the questions they should ask about [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). There is lots of health information on prostate cancer, including information about how best to ask questions about the disease and information on prevention, screening, detection, and treatment options when prostate-related disease is suspected. The American Cancer Society and the National Comprehensive Cancer Network both provide great information about prostate cancer and treatment options. It is a disease that typically affects older men but is not uncommon to be diagnosed at a younger age." - Anonymous Online Contributor

Unverified Answer

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

"The most common [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in the population is multifocal or multicentric; nearly 25% of men will be diagnosed with this disease. Multifocal disease is commonly found on repeat biopsy, suggesting that focal disease might be missed when repeat biopsy is conducted. Prostate cancer is one of the more frequent benign findings on repeat core biopsy, and in patients with multifocal disease most cores demonstrate cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"Many patients with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) suffer from benign prostatic hyperplasia (BPH), a condition in which the prostate does not function properly and causes problems such as painful urination during ejaculation, and incontinence. Treatment options include surgery, radiation therapy, chemotherapeutic/targeted therapy, behavioral therapy, and hormonal therapy." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"Several factors including diet, hormone replacement, radiation exposure, and lifestyle play a role in prostate cancer. Although prostate cancer happens in men of all ages and races, prostate cancer happens in men over the age of 50 and particularly in African American men." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving focal salvage hdr prostate brachytherapy?

"It is the first and only study of its type in Europe, and the only study investigating the use of hd-BRT, in addition to ISR. There was no evidence of a benefit of Hd-BRT in the ISR setting, and no difference in PSA values, in the Hd-BRT group and control group. We found a trend towards significance in respect of PSA values, but the results failed to reach the threshold for a statistical significance in this study: P (t)=0.055. It is the first report to our knowledge about this form of salvage therapy, and will be used as a basis for a larger study." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets prostate cancer?

"Prostate cancer was diagnosed earlier in all age groups in 2018 compared to the previous two decades. Although incidence rates of prostate cancer increased with age, prevalence rates rose sharply in a more steep proportion with age. The current findings are consistent with predictions that age-related changes in cancer pathobiology and risk factors may contribute. Further research is needed to explore the relationship of age to the time of diagnosis, the cause of early diagnoses, and whether the increase in the age of diagnosis has a real health problem." - Anonymous Online Contributor

Unverified Answer

Is focal salvage hdr prostate brachytherapy typically used in combination with any other treatments?

"Compared with other salvage options, FSHPB is often used in conjunction with other treatment options, particularly in patients with a high risk of disease recurrence." - Anonymous Online Contributor

Unverified Answer

How quickly does prostate cancer spread?

"Men with intermediate risk Gleason 6 [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) may benefit from active surveillance after adjusting for pretreatment PSA level. However, more men (33%) will eventually undergo radical prostatectomy. The PSA rate may be an indicator of the extent of disease before radical prostatectomy and of the likelihood of cancer recurrence." - Anonymous Online Contributor

Unverified Answer

What does focal salvage hdr prostate brachytherapy usually treat?

"Data from a recent study confirms that the risk of focal salvage brachytherapy is extremely low, and more so than in other studies in which no comparison to postirradiation prostatic atrophy was made. As well, the results are not comparable to those reported in other studies, owing to the study design and the use of different staging schemes. We therefore feel that patients who have previously undergone prostatectomy for local control of their disease might be the ideal candidates for local salvage brachytherapy." - 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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