HDR vs LDR Brachytherapy for Prostate Cancer

(LDR/HDRmono Trial)

Overseen By Francois Bachand, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must not be taking: Androgen deprivation therapy

Disqualifiers: Prior prostate surgery, Pelvic radiation, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 37

Duration: 2-4 weeks

140 Participants Needed

Trial Summary

What is the purpose of this trial?

H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study H15-02103

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it does mention that participants should not be on androgen deprivation therapy (a treatment to lower male hormones).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have had androgen deprivation therapy (a treatment to lower male hormones).

What data supports the effectiveness of the treatment HDR vs LDR Brachytherapy for Prostate Cancer?

Both high-dose-rate (HDR) and low-dose-rate (LDR) brachytherapy are recommended treatments for prostate cancer, with studies showing that LDR brachytherapy has excellent long-term cancer control and functional outcomes. HDR brachytherapy is considered advanced and potentially more beneficial in some aspects, but it is still largely experimental outside of clinical trials. ^{1 2 3 4 5}

What data supports the effectiveness of HDR vs LDR Brachytherapy for Prostate Cancer treatment?

Both high-dose-rate (HDR) and low-dose-rate (LDR) brachytherapy are recommended treatments for prostate cancer, with studies showing that LDR brachytherapy has excellent long-term outcomes. HDR brachytherapy is considered advanced and has shown promising results in terms of patient survival and reduced side effects, but it is still considered experimental outside of clinical trials. ^{1 2 3 4 5}

Is HDR and LDR brachytherapy safe for prostate cancer treatment?

Both high-dose-rate (HDR) and low-dose-rate (LDR) brachytherapy are considered safe for treating prostate cancer, with studies showing encouraging results in terms of patient survival and treatment side effects. HDR brachytherapy is still considered experimental outside of clinical trials, but both techniques have been shown to safely deliver radiation to the prostate while minimizing exposure to surrounding tissues. ^{1 2 5 6 7}

Is HDR and LDR brachytherapy safe for prostate cancer treatment?

Both high-dose-rate (HDR) and low-dose-rate (LDR) brachytherapy are considered safe for treating prostate cancer, with studies showing encouraging results in terms of patient survival and treatment side effects. HDR brachytherapy is still considered experimental as a standalone treatment, but both methods are established and evolving techniques for prostate cancer. ^{1 2 5 6 7}

How does HDR vs LDR brachytherapy for prostate cancer differ from other treatments?

HDR (High Dose Rate) and LDR (Low Dose Rate) brachytherapy are unique treatments for prostate cancer that involve placing radioactive material directly into or near the tumor. HDR is a temporary and more invasive procedure with precise control over radiation delivery, while LDR involves permanent seed implants and is typically a one-time procedure. Both methods are effective in reducing radiation exposure to surrounding organs compared to other treatments like VMAT (Volumetric Modulated Arc Therapy). ^{1 2 5 8 9}

How does HDR and LDR brachytherapy for prostate cancer differ from other treatments?

HDR and LDR brachytherapy for prostate cancer are unique because they involve placing radioactive material directly in or near the tumor, allowing for targeted radiation. HDR brachytherapy is temporary and allows precise control over radiation delivery, while LDR brachytherapy involves permanent seed implants. Both methods reduce radiation exposure to surrounding healthy tissues compared to other treatments like VMAT (a type of external beam radiation therapy). ^{1 2 5 8 9}

Research Team

Ross Halperin, MD

Principal Investigator

British Columbia Cancer Agency Program Director

Eligibility Criteria

Men with favorable to intermediate-risk prostate cancer, who have a life expectancy of at least 10 years and are not candidates for active surveillance. They should have no prior radical prostate surgeries or treatments like TURP, cryosurgery, pelvic radiation, or chemotherapy for prostate cancer. Their PSA levels and Gleason scores must meet specific criteria.

Inclusion Criteria

My prostate cancer is at an early or intermediate stage, and I am expected to live 10 more years.

My prostate cancer is at an early stage, with specific test results.

My prostate cancer is at an early stage, with low PSA and Gleason scores, and I'm mostly active.

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

I have had surgery or cryotherapy for prostate issues before.

I have had major surgery for prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low dose rate or high dose rate prostate brachytherapy. LDR is delivered in a single session, while HDR is delivered in two sessions, two weeks apart.

2-4 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for safety, quality of life, and treatment efficacy. Follow-up assessments include imaging, symptom tracking, and biopsies.

36 months

Multiple visits over 36 months

Long-term Follow-up

Long-term monitoring of biochemical outcomes and toxicity, with assessments up to 10 years.

10 years

Treatment Details

Interventions

• High dose rate prostate brachytherapy
• Low dose rate prostate brachytherapy

Trial Overview This trial compares two types of internal radiation therapy for treating prostate cancer: high dose rate (HDR) vs. low dose rate (LDR) brachytherapy. It's designed to see which method is more effective in patients with certain risk levels of prostate cancer.

Participant Groups

Group I: High dose rate brachytherapy Experimental Treatment 1 Intervention

Device: Radiation. High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anesthesia, but no follow-up imaging visit is required. HDR brachytherapy is also accomplished as an out-patient.

Group II: Low dose rate brachytherapy Active Control 1 Intervention

Device: Radiation. Low dose rate prostate brachytherapy is delivered under anesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality.

High dose rate prostate brachytherapy is already approved in European Union, United States, Canada, United Kingdom for the following indications:

Approved in European Union as HDR Brachytherapy for:

• Localized prostate cancer
• Recurrent prostate cancer

Approved in United States as HDR Brachytherapy for:

• Localized prostate cancer
• Recurrent prostate cancer

Approved in Canada as HDR Brachytherapy for:

• Localized prostate cancer
• Recurrent prostate cancer

Approved in United Kingdom as HDR Brachytherapy for:

• Localized prostate cancer
• Recurrent prostate cancer

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

BC Cancer Foundation

Collaborator

Trials

20

Recruited

8,600+

Findings from Research

Both low-dose rate (LDR) and high-dose rate (HDR) brachytherapy provide effective tumor control for localized prostate cancer, with similar outcomes based on current clinical data and radiobiological modeling of tumor control probabilities.

HDR brachytherapy, especially with dose escalation, may offer superior tumor control compared to LDR, particularly for prostate cancers that are more sensitive to dose fractionation, suggesting potential for improved treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LDR vs. HDR brachytherapy for localized prostate cancer: the view from radiobiological models. King, CR.[2022]

A study of 50,326 patients with localized prostate cancer from 2004 to 2014 found that while both high-dose-rate (HDR) and low-dose-rate (LDR) brachytherapy are effective, the use of HDR has declined over time, from 27% in 2004 to 19.2% in 2014.

Despite similar overall survival rates (127.0 months for HDR and 125.4 months for LDR), factors such as age, treatment at academic centers, and income influenced the likelihood of receiving HDR over LDR, indicating a shift in treatment patterns rather than differences in efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment patterns of high-dose-rate and low-dose-rate brachytherapy as monotherapy for prostate cancer. Barnes, J., Kennedy, WR., Fischer-Valuck, BW., et al.[2023]

In a study of 201 patients treated with low-dose-rate (LDR) brachytherapy for localized prostate cancer, there was a significant and persistent decline in prostate-specific antigen (PSA) levels over time, indicating effective cancer control.

After 10 years of follow-up, only 9 patients experienced tumor recurrence, and while some urinary symptoms were noted initially, they significantly decreased after 18 months, suggesting that LDR brachytherapy is both safe and effective with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose-rate brachytherapy as a minimally invasive curative treatment for localised prostate cancer has excellent oncological and functional outcomes: a retrospective analysis from a single centre. D'hulst, P., Mattelaer, P., Darras, J., et al.[2022]

In a study of 832 patients with localized prostate cancer treated with high-dose-rate brachytherapy (HDR-BT) and external beam radiotherapy (EBRT), higher biologically effective doses (BED) correlated with improved biochemical failure-free survival (BFFS) rates, particularly in the group receiving doses greater than 260Gy.

While higher BED regimens showed better control of PSA levels, the increase in urinary toxicity was minimal and considered clinically acceptable, with only a small percentage of patients experiencing severe toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy boost for prostate cancer treatment: Different combinations of hypofractionated regimens and clinical outcomes. Vigneault, E., Mbodji, K., Magnan, S., et al.[2022]

High-dose rate brachytherapy (HDR-BT) shows promising results in controlling prostate cancer and preserving erectile function, making it a potentially advantageous alternative to low-dose rate brachytherapy (LDR-BT).

Despite its benefits, HDR-BT is still considered experimental and not yet recommended as a standard treatment for prostate cancer outside of clinical trials, indicating the need for further research to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do theoretical potential and advanced technology justify the use of high-dose rate brachytherapy as monotherapy for prostate cancer? Zaorsky, NG., Doyle, LA., Hurwitz, MD., et al.[2014]

In a study of 164 men treated with high-dose-rate (HDR) brachytherapy for prostate cancer, the procedure showed a low incidence of genitourinary (GU) and gastrointestinal (GI) complications, indicating it is a safe treatment option.

With a median follow-up of 18.6 months, HDR brachytherapy resulted in a high overall survival rate of 98.7% and a disease-free survival rate of 96.2%, demonstrating its efficacy in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. Zhang, H., Kang, S., Ali, N., et al.[2022]

Prostate brachytherapy, whether using permanent Low Dose Rate (LDR) or temporary High Dose Rate (HDR) techniques, is an effective treatment for non-metastatic prostate cancer, allowing for safe radiation dose escalation while minimizing damage to surrounding tissues.

Clinical evidence shows that brachytherapy improves PSA control compared to external beam radiotherapy alone, making it a valuable option in prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GEC-ESTRO ACROP prostate brachytherapy guidelines. Henry, A., Pieters, BR., André Siebert, F., et al.[2022]

Low-dose-rate (LDR) brachytherapy is a one-time procedure with a long history of excellent outcomes and low side effects, making it the gold standard for low-risk prostate cancer patients.

High-dose-rate (HDR) brachytherapy, while more invasive and requiring multiple sessions, offers better control over dosimetry, allowing for safe dose escalation, but lacks extensive long-term data compared to LDR. Both techniques show equivalent effectiveness in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose-rate or high-dose-rate brachytherapy in treatment of prostate cancer - between options. Skowronek, J.[2022]

In a study involving 10 patients with localized prostate cancer, both high-dose rate (HDR) and low-dose rate (LDR) brachytherapy techniques significantly reduced radiation exposure to critical organs like the rectum and bladder compared to volumetric modulated arc therapy (VMAT).

HDR brachytherapy was particularly effective in sparing the urethra from radiation damage compared to both VMAT and LDR, highlighting its potential as a safer treatment option for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and radiobiological comparison of volumetric modulated arc therapy, high-dose rate brachytherapy, and low-dose rate permanent seeds implant for localized prostate cancer. Yang, R., Zhao, N., Liao, A., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

LDR vs. HDR brachytherapy for localized prostate cancer: the view from radiobiological models. [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

Treatment patterns of high-dose-rate and low-dose-rate brachytherapy as monotherapy for prostate cancer. [2023]

3. Poland pubmed.ncbi.nlm.nih.gov

Low-dose-rate brachytherapy as a minimally invasive curative treatment for localised prostate cancer has excellent oncological and functional outcomes: a retrospective analysis from a single centre. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy boost for prostate cancer treatment: Different combinations of hypofractionated regimens and clinical outcomes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Do theoretical potential and advanced technology justify the use of high-dose rate brachytherapy as monotherapy for prostate cancer? [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

GEC-ESTRO ACROP prostate brachytherapy guidelines. [2022]

8. Poland pubmed.ncbi.nlm.nih.gov

Low-dose-rate or high-dose-rate brachytherapy in treatment of prostate cancer - between options. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Dosimetric and radiobiological comparison of volumetric modulated arc therapy, high-dose rate brachytherapy, and low-dose rate permanent seeds implant for localized prostate cancer. [2017]