LDR Brachytherapy and External Beam Radiation Therapy for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
BC Cancer - Vancouver, Vancouver, Canada
Prostate Cancer+1 More
LDR Brachytherapy and External Beam Radiation Therapy - Radiation
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a brachytherapy implant can be used to treat prostate cancer with less side effects.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Study Objectives

This trial is evaluating whether LDR Brachytherapy and External Beam Radiation Therapy will improve 1 primary outcome and 1 secondary outcome in patients with Prostate Cancer. Measurement will happen over the course of Analysis to be done at median follow-up of 2 years.

2 years
Trans-perineal biopsy and imaging correlation
Year 2
Frequency of treatment-related GU adverse effects

Trial Safety

Trial Design

2 Treatment Groups

Control
Combined radiation treatment

This trial requires 105 total participants across 2 different treatment groups

This trial involves 2 different treatments. LDR Brachytherapy And External Beam Radiation Therapy 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.

Combined radiation treatment
Radiation
Combined low-dose-rate brachytherapy and external beam radiation therapy
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

BC Cancer - Vancouver - Vancouver, Canada

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Prostate Cancer or the other condition listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have histologically-proven prostate cancer
Patients must meet either: a. National Comprehensive Cancer Network (NCCN) definition of high-risk disease or b. Intermediate-risk disease with at least 3 points using the following scale: One point each for clinical stage = T2b-c, iPSA >7 ng/mL, and Gleason grade group 2 (overall Gleason sum 3+4 =7), Two points for Gleason grade group 3 (overall Gleason sum 4+3 =7).
Patients must have N0 M0 status on the basis of technetium bone scan and computed tomography (CT) scan of the pelvis

Patient Q&A Section

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

What is the average age someone gets prostate cancer?

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Prostate cancer occurs most frequently in elderly men, but it is still relatively uncommon in young men. Older men get prostate cancer and have lower mortality than younger men.

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What causes prostate cancer?

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The cause of prostate cancer is unknown. Possible causes include genetic factors and environmental factors. Because prostate cancers affect both men of European descent and African-Americans, there is some evidence that other genes may play a role in the development of prostate cancer.

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What is prostate cancer?

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Prostate cancer typically forms in the prostate gland and is rarely found in the testes or rectum. Older men have a higher proportion of prostate cancers that have spread to the skin, bones, or lymph nodes. Most prostate cancers have benign prostate morphology or Gleason sums of 6 or lower. Most men have cancers that have progressed over time. Prostate cancer is often detected during a routine PSA test. It is most often detected by frequent and/or bloody urination. Most prostate cancers are found because of a biochemical, prostate-specific antigen (PSA) test. However, most prostate cancers do not cause symptoms and are treated by watchful waiting.

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What are the signs of prostate cancer?

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The signs of the [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) depend on the stage and size of the tumor, and may be related to high serum PSA levels or other benign conditions of the prostate. In all cases, however, they can be divided into three domains: \n- Symptomatic signs of inflammation or irritation, e.g., urinary tract symptoms (i.e., hesitancy to urinate and/or urgency to urinate); hematuria; lower abdominal pain; or urinary urgency and frequent or painful urination (i.e., frequency >10 times/day and/or passage of more blood per urination).\n- Hematological signs of chronic inflammation, e.g.

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

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The current American Cancer Society estimates that 22,720 new diagnoses of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) will be made in 2022. At a rate of 21,827 new diagnoses per year, the estimated 5 year risk of developing prostate cancer in men born in 2000 is 3.62%. About 15,000 men with this type of disease were alive in the year 2000. This incidence rate is consistent with the estimates found in other developed countries with very low rates of prostate cancer. There is no indication that the incidence of prostate cancer is rising in the United States.

Unverified Answer

What are common treatments for prostate cancer?

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Prostate cancer continues to be prevalent and has high rates of metastasis, making effective treatments much more important than ever before. Treatment depends on many factors, such as the stage of the disease, comorbidities in the form of androgens, and age of the patients. Treatments are primarily targeted towards symptom control. Anticancer therapies exist, but are more often as adjuvant treatments rather than curative treatments.\n

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Can prostate cancer be cured?

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The term 'cured' is a misnomer, as prostate cancer is unlikely to be eradicated from the body, especially if biochemical tumour control has not been achieved. In the absence of clinical evidence of disease and with the knowledge that death from prostate cancer is a terminal and curable disease, the term 'cure' is misleading. However, it seems that men with an early diagnosis of prostate cancer may be able to live a normal life expectancy, which may be equivalent to what is achievable with current treatment options.

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Who should consider clinical trials for prostate cancer?

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In the past, most men were not counseled about clinical trials for prostate cancer but are now frequently invited to attend a decision support seminar where they can learn about the pros and cons of clinical trials. Before deciding about clinical trials, this education should include: risk, expected benefits, study design, and the type of patient eligible to participate in a trial, so that people making decisions about therapies think before doing so.

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Is ldr brachytherapy and external beam radiation therapy typically used in combination with any other treatments?

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Among those men that were receiving curative radiation therapy, LDR prostate brachytherapy was not used commonly in combination with other treatments. This is contrary to other reports where prostate brachytherapy was used as and important treatment option prior to or at the time of other medical treatments. Data from a recent study may be attributed to a lack of evidence regarding the use of prostate brachytherapy in combination with another treatment modality. The limitations of this study, however, include the retrospective nature of this review.

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What is the primary cause of prostate cancer?

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In men with clinical suspicion of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), incidental microscopic prostate cancer was detected by the PSA test in approximately half of the cases. The risk factors for prostate cancer depend on the location of prostate cancer as prostate cancer is rarely detected in the urethral region. Therefore, urethral prostate cancer should not be treated as benign. However, incidental detection of prostate cancer by the PSA test or by the TRUS in men with normal PSA values should be treated as suspect prostate cancer. A high pretest probability of prostate cancer should alert physicians to look for prostate cancers during a repeat prostate examination or at autopsy.

Unverified Answer

Is ldr brachytherapy and external beam radiation therapy safe for people?

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This treatment is safe. LDR prostate brachytherapy and EBRT should be recommended to all patients with localized prostate cancer and clinically LDR brachytherapy has advantages in terms of reduced treatment time, less toxicity, and equal or better control.

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What are the chances of developing prostate cancer?

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Age at diagnosis in the general population is very much associated with the risk of developing prostate cancer. The age-adjusted relative risk is 1.9. Age-adjusted relative risks in the groups above the age of 85 years are 10.6. These ratios are similar if the diagnosis is based on symptomatic presentation of high-risk prostate cancer. A simple tool, based on age and PSA test level, can be used to predict the risk of a man developing prostate cancer.

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