HDR Brachytherapy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Washington University School of Medicine
Must be taking: Androgen deprivation
Must not be taking: Investigational agents
Disqualifiers: Other malignancy, Uncontrolled illness, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy, you may continue it as part of the trial.
What data supports the effectiveness of the treatment HDR brachytherapy for prostate cancer?
Research shows that HDR brachytherapy, often combined with external beam radiation, is effective in treating prostate cancer, with a high percentage of patients remaining disease-free and having good survival rates. Studies have demonstrated its safety and efficacy, especially in intermediate- and high-risk patients, and it has been shown to improve outcomes compared to external beam radiation alone.
12345Is HDR brachytherapy generally safe for humans?
Research shows that HDR brachytherapy is generally safe for treating prostate cancer, with studies reporting only mild side effects like minor urinary and gastrointestinal issues. No severe adverse events were noted, indicating it is a safe treatment option.
678910How is HDR brachytherapy different from other prostate cancer treatments?
HDR brachytherapy is unique because it delivers high doses of radiation directly to the prostate in a short period, minimizing exposure to surrounding healthy tissues. This method is particularly effective for prostate cancer due to the tumor's sensitivity to increased radiation doses, and it can be used alone or with other treatments like external beam radiation.
1112131415Eligibility Criteria
Men at least 18 years old with early stage prostate cancer, either low-risk or favorable intermediate-risk, may join this trial. They can have had hormone therapy within the last 6 months. Participants must be able to perform daily activities with minimal assistance and sign a consent form. Men who've had certain prior treatments or have serious health issues like heart disease, large TURP defects, or other recent cancers cannot participate.Inclusion Criteria
My prostate cancer was confirmed through a biopsy.
My prostate cancer is classified as low-risk or favorable intermediate-risk.
I am 18 years old or older.
+3 more
Exclusion Criteria
I cannot have general, spinal, or local anesthesia.
I had a prostate surgery that might affect the placement of an implant.
I do not have any uncontrolled illnesses like infections or heart problems.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single implant and single HDR fraction of either 21 Gy, 23 Gy, or 25 Gy within a 24-hour period
1 day
1 visit (in-person)
Follow-up
Participants are monitored for acute toxicity and biochemical control
3 months
Multiple visits (in-person)
Long-term follow-up
Participants are monitored for late toxicity and biochemical control
3 years
Participant Groups
This study tests different doses (21 Gy, 23 Gy, and 25 Gy) of high dose rate brachytherapy for treating early stage prostate cancer. Brachytherapy involves placing radioactive material inside the body to kill cancer cells.
3Treatment groups
Experimental Treatment
Group I: HDR brachytherapy - 25 GyExperimental Treatment1 Intervention
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 25 Gy.
Group II: HDR brachytherapy - 23 GyExperimental Treatment1 Intervention
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy.
Group III: HDR brachytherapy - 21 GyExperimental Treatment1 Intervention
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 21 Gy.
HDR brachytherapy is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as High Dose Rate Brachytherapy for:
- Localized prostate cancer
- Locally advanced prostate cancer
- Recurrent prostate cancer
🇺🇸 Approved in United States as High Dose Rate Brachytherapy for:
- Early-stage prostate cancer
- Intermediate-risk prostate cancer
- High-risk prostate cancer
🇨🇦 Approved in Canada as High Dose Rate Brachytherapy for:
- Prostate cancer
- Recurrent prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
References
[High dosage brachytherapy and external irradiation of localized prostate carcinoma--results at the Kiel University Clinic]. [2018]To evaluate a new therapy protocol for local dose escalation by high dose rate (HDR) brachytherapy for survival, morbidity and prognostic variables in men with localized prostate cancer. The prospectively recorded files of 189 men aged in median 69 years with a mean follow-up of 6 years (12-143 months) receiving curatively intended combined high dose rate (HDR) 192-iridium-brachytherapy (BT) and external beam radiation (EBR) for locally confined prostate cancer were analyzed. Mean age was 68.2 (range 44-84 years). Hundred and twenty-seven patients had T1-2 tumors, and 62 patients had T3-tumors. The total planned dose applied by external beam radiation was 50 Gy in the pelvis, and 40 Gy in the prostate by in-field-dose modification. The HDR-brachytherapy was delivered in two fractions. The dose per fraction amounted 15 Gy. Mean survival was 6 years (range 12-143 months), 76.7% of the patients survived and 86.3% were disease-free. The biochemical non-evidence of disease rate (BNED) was 78%. Univariate survival analysis revealed that low stage (T1-2), low grade (G1-2), normal PSA status after radiation therapy, and no adjuvant hormonal treatment were associated with long survival. However, the stratification for adjuvant hormonal treatment was not according to random. In multivariate analyses PSA status was an independent prognostic factor. The six year results confirm that local dose escalation by HDR-brachytherapy and external beam radiation is curative in men with locally confined prostate cancer. The results are especially in high risk patients encouraging.
Improved survival for patients with prostate cancer receiving high-dose-rate brachytherapy boost to EBRT compared with EBRT alone. [2019]High-dose-rate (HDR) brachytherapy boost is a treatment of intermediate- to high-risk prostate cancer, but long-term clinical outcome data are sparse. We report long-term survival and toxicity data in a cohort of patients treated in a single institution.
Role of high dose rate brachytherapy in the treatment of prostate cancer. [2012]High dose rate (HDR) brachytherapy in intermediate and high-risk prostate cancer patients has started in the late eighties in Europe and the United States, as a boost combined with external beam radiation therapy, as an attractive method for dose escalation. The results of the first dose-escalation study performed at William Beaumont Hospital has established the safety and efficacy of this combined treatment approach. Likewise, this landmark study enabled a paradigm shift in the radiobiology of prostate cancer, demonstrating that the alpha/beta of prostate cancer was much lower than previously believed to be and therefore the sensitivity of this tumor model to higher-than-conventional doses per fraction led to a dramatic increase of hypofractionated treatment regimens, the object of significant clinical research efforts, currently under way. The excellent toxicity profile and clinical outcome of HDR boost combined treatment prompted investigators to expand HDR brachytherapy indications to low/intermediate prostate cancer patients as the sole treatment modality. The results, toxicity and a brief review of the literature for both HDR boost and HDR monotherapy will be presented.
Long-term outcomes of high-dose-rate brachytherapy for intermediate- and high-risk prostate cancer with a median follow-up of 10 years. [2018]To evaluate the long-term outcomes of high-dose-rate (HDR) brachytherapy for patients with intermediate- and high-risk prostate cancer.
Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. [2021]High dose-rate (HDR) brachytherapy as monotherapy is a treatment option for localized prostate cancer, but optimal dose and fractionation is unknown. We report efficacy results of a randomized phase II trial of HDR monotherapy delivered as either one or two fractions.
Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. [2022]Growing evidence supports the efficacy and safety of high-dose-rate (HDR) brachytherapy as a boost or monotherapy in prostate cancer treatment. We initiated a new HDR prostate brachytherapy practice in April 2014. Here, we report the learning experiences, short-term safety, quality, and outcome.
[Brachytherapy as monotherapy for prostate cancer with the use of temporary sources]. [2019]The aim of this study was to investigate disease-free sur- vival and toxicity of high-dose rate brachytherapy (HDR-BT) in patients with prostate cancer at low risk of progression in monotherapy. With the use of advanced methods of imaging and planning brachytherapy allows achieving a high accuracy of radiotherapy delivering the adequate dose to the prostate and in the same time minimizing the toxic effects from adjacent organs. Brachytherapy by Ir-192 was carried out in 20 patients, in the form of monotherapy 3 fractions in a single focal dose 10 Gy with a two-week interruption between fractions to a total focal dose 30 Gy. Biologically effective dose was 230 Gy. The percentage of the prescribed dose on organ-target (V100) was not less than 95% (average 97.1 %). The critical dose on the urethra and the rectum was 110% and 70% of the prescribed dose respectively. The early and late radiation toxic reactions from genitourinary system and gastrointestinal tract in all of them were marked only as I grade. There were no adverse events of II-IV grades. Therefore HDR-BT as monotherapy has proved to be a safe and effective method of treatment prostate cancer patients of low risk of progression. Disease-free 5-year survival was 100% while minimizing toxic reactions from adjacent organs.
Patient- and treatment-specific predictors of genitourinary function after high-dose-rate monotherapy for favorable prostate cancer. [2022]High-dose-rate (HDR) brachytherapy alone is an effective treatment option for patients with early-stage prostate cancer. The purpose of this study was to quantify patient-reported short- and long-term toxicity and quality of life (QOL) after HDR monotherapy.
Prostate high dose rate brachytherapy in a free-standing cancer center setting. [2016]To determine the safety and acute tolerance of performing prostate high dose rate (HDR) brachytherapy in a free-standing cancer center setting, and to report our approach in delivering such treatment.
High-dose-rate brachytherapy delivered in two fractions as monotherapy for low-risk prostate cancer. [2020]High-dose-rate (HDR) brachytherapy has been accepted as an effective and safe method to treat prostate cancer. The aim of this study was to describe acute toxicity following HDR brachytherapy to the prostate, and to examine the association between dosimetric parameters and urinary toxicity in low-risk prostate cancer patients.
High-dose-rate brachytherapy as monotherapy for prostate cancer: technique, rationale and perspective. [2021]High-dose-rate (HDR) brachytherapy as monotherapy is a comparatively new brachytherapy procedure for prostate cancer. Although clinical results are not yet mature enough, it is a highly promising approach in terms of potential benefits for both radiation physics and radiobiology. In this article, we describe our technique for monotherapeutic HDR prostate brachytherapy, as well as the rationale and theoretical background, with educational intent.
HDR Brachytherapy in the Management of High-Risk Prostate Cancer. [2021]High-dose-rate (HDR) brachytherapy is used with increasing frequency for the treatment of prostate cancer. It is a technique which allows delivery of large individual fractions to the prostate without exposing adjacent normal tissues to unacceptable toxicity. This approach is particularly favourable in prostate cancer where tumours are highly sensitive to dose escalation and to increases in radiotherapy fraction size, due to the unique radiobiological behaviour of prostate cancers in contrast with other malignancies. In this paper we discuss the rationale and the increasing body of clinical evidence for the use of this technique in patients with high-risk prostate cancer, where it is combined with external beam radiotherapy. We highlight practical aspects of delivering treatment and discuss toxicity and limitations, with particular reference to current practice in the United Kingdom.
Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. [2018]The intrinsic physical and radiobiological characteristics of High Dose Rate Brachytherapy (HDR-BT) are well suited to the treatment of prostate cancer. HDR-BT was initially used as a boost to external beam brachytherapy, but has subsequently been employed as the sole treatment, which is termed HDR monotherapy. This review summarizes the clinical outcomes and toxicity results of the principal studies and discusses the radiobiological basis supporting its use.
Analytical HDR prostate brachytherapy planning with automatic catheter and isotope selection. [2023]High dose rate (HDR) brachytherapy is commonly used to treat prostate cancer. Existing HDR planning systems solve the dwell time problem for predetermined catheters and a single energy source.
American Brachytherapy Society consensus guidelines for high-dose-rate prostate brachytherapy. [2022]A well-established body of literature supports the use of high-dose-rate (HDR) brachytherapy as definitive treatment for localized prostate cancer. Most of the articles describe HDR as a boost with adjuvant external beam radiation, but there is a growing experience with HDR monotherapy.