Brachytherapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Advanced prostate cancer, Metastases, Prior prostate surgery, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn if a prostate implant (brachytherapy) can help to control intermediate risk prostate cancer. The safety of this procedure will also be studied. Prostate brachytherapy is performed by inserting permanent seeds (which are radioactive pellets) into your prostate in order to treat the prostate cancer with radiation therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, alpha blockers are allowed if you have AUA voiding symptoms.

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

Brachytherapy, which involves placing radioactive seeds in the prostate, is effective for treating prostate cancer, with studies showing about 90% of patients maintaining control over their cancer without late failures. It also results in fewer side effects like erectile dysfunction and urinary incontinence compared to surgery. ^{1 2 3 4 5}

Is brachytherapy for prostate cancer generally safe for humans?

Brachytherapy for prostate cancer, which involves implanting radioactive seeds, is generally considered safe, but there are some risks. These include potential seed migration to the lungs and side effects like urinary symptoms and inflammation of the rectum. Studies are ongoing to better understand and minimize these risks. ^{5 6 7 8 9}

How does brachytherapy differ from other treatments for prostate cancer?

Brachytherapy for prostate cancer involves placing radioactive seeds directly into the prostate, delivering radiation precisely to the cancer while sparing nearby healthy tissue. This method is less disruptive for patients compared to other treatments like surgery or external radiation, and it is performed as an outpatient procedure. ^{1 4 5 10 11}

Research Team

Steven J. Frank

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for men over 18 with intermediate risk prostate cancer, no distant metastases, and a good performance status. They must have a prostate volume ≤60 cc by ultrasound, low urinary symptoms, and specific PSA levels. Prior treatments like surgery or radiation for prostate cancer disqualify them.

Inclusion Criteria

My prostate is 60 cc or smaller, as measured by ultrasound.

My prostate cancer is in the early stages and hasn't spread to lymph nodes or other parts.

My prostate cancer is intermediate risk with specific PSA and Gleason scores.

Exclusion Criteria

My cancer has spread to nearby lymph nodes.

My cancer is not in the most advanced stages.

I have had major surgery or treatments for prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Planning

Ultrasound of the prostate is performed to measure and map the prostate for brachytherapy planning

1 day

1 visit (in-person)

Brachytherapy Treatment

Brachytherapy implant procedure performed under anesthesia, involving insertion of radioactive seeds into the prostate

1-2 hours

1 visit (in-person)

Initial Follow-up

First follow-up visit to assess seed placement and patient recovery

4-6 weeks after treatment

1 visit (in-person)

Long-term Follow-up

Regular follow-up visits to monitor patient health and treatment effectiveness, including physical exams, blood tests, and questionnaires

5 years

Visits at 4, 8, 12 months, then every 6 months until 5 years, then annually

Treatment Details

Interventions

• Brachytherapy

Trial Overview The study tests brachytherapy's effectiveness in controlling intermediate risk prostate cancer. It involves implanting radioactive seeds into the prostate to deliver targeted radiation therapy. Participants' safety and responses are monitored through questionnaires.

Participant Groups

Group I: Brachytherapy - Participants with > 35% biopsy core Experimental Treatment 2 Interventions

Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.

Group II: Brachytherapy - Participants with < 35% biopsy core Experimental Treatment 2 Interventions

Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.

Brachytherapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Approved in European Union as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer
• Brain tumors

Approved in Canada as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Transrectal ultrasound-guided prostate brachytherapy is the most advanced method for delivering radiation, achieving lower prostate-specific antigen (PSA) levels than other treatments like IMRT, while maintaining biochemical control in about 90% of patients.

Brachytherapy as an organ-conserving treatment results in lower rates of erectile dysfunction and urinary incontinence compared to surgery, making it a safer option for patients with low-risk prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on prostate brachytherapy: long-term outcomes and treatment-related morbidity. Kao, J., Cesaretti, JA., Stone, NN., et al.[2022]

Permanent seed brachytherapy is a suitable treatment option for patients with low-risk localized prostate cancer, characterized by specific criteria such as T1-2 stage, PSA levels under 10 ng/mL, and well-differentiated cancer (Gleason score less than 7).

The 10-year outcomes in terms of cancer control and side effects from brachytherapy are comparable to other standard treatments like radical prostatectomy and external beam radiation therapy, highlighting its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Techniques, indications and results of permanent prostate brachytherapy for localized prostate cancer]. Bladou, F., Thuret, R., Gravis, G., et al.[2019]

Brachytherapy, which involves the permanent implantation of radioactive seeds, shows promising results for treating early-stage prostate cancer, particularly in patients with favorable tumor characteristics, achieving biochemical failure rates comparable to radical prostatectomy.

While acute urinary retention occurred in 1%-14% of patients, long-term side effects were low (less than 5%), and a high percentage (86%-96%) of patients maintained sexual potency after treatment, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic overview of the evidence for brachytherapy in clinically localized prostate cancer. Crook, J., Lukka, H., Klotz, L., et al.[2018]

In a study of 130 patients treated with permanent I-125 seed implants for prostate cancer, the procedure showed a high biochemical relapse-free survival rate of 98.9% at one year and 87.8% at two years, indicating its efficacy in managing organ-confined prostate cancer.

The treatment was associated with low rates of acute toxicity, with only 1.4% experiencing mild rectal toxicity and 4.3% requiring intervention for acute urinary retention, suggesting that the procedure is well-tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Retrospective study of 130 patients with organconfined prostate cancer treated with brachytherapy]. Aguiló Lucía, F., Suárez Novo, JF., Correa Generoso, R., et al.[2019]

References

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

Modern prostate brachytherapy. [2022]

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

Update on prostate brachytherapy: long-term outcomes and treatment-related morbidity. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Techniques, indications and results of permanent prostate brachytherapy for localized prostate cancer]. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Systematic overview of the evidence for brachytherapy in clinically localized prostate cancer. [2018]

5. Spain pubmed.ncbi.nlm.nih.gov

[Retrospective study of 130 patients with organconfined prostate cancer treated with brachytherapy]. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Bioevaluation of (125) I Ocu-Prosta seeds for application in prostate cancer brachytherapy. [2021]

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

Experimental measurements and Monte Carlo simulations of dose perturbation around a nonradioactive brachytherapy seed due to 6- and 18-MV photons. [2013]

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

Reduction of radioactive seed embolization to the lung following prostate brachytherapy. [2022]

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

Critical organ dosimetry in permanent seed prostate brachytherapy: defining the organs at risk. [2007]

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

Prostate cancer treatment with radioactive seed implantation. [2019]

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

Brachytherapy: update and results. [2022]