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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a prostate implant called brachytherapy can control intermediate-risk prostate cancer. Brachytherapy involves placing tiny radioactive seeds inside the prostate to target cancer cells with radiation. The trial aims to assess the safety and effectiveness of this treatment for participants. Men with prostate cancer who meet specific risk criteria and have not undergone certain prior treatments may qualify. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that this brachytherapy procedure is safe for prostate cancer treatment?

Research shows that brachytherapy, which involves placing tiny radioactive seeds in the prostate, is generally safe for treating prostate cancer. Studies have found it to be well-tolerated, with long-term survival rates exceeding 95%. Patients undergoing brachytherapy experience outcomes similar to those receiving other radiation treatments, with no major safety issues reported. Additionally, combining brachytherapy with other treatments has proven effective and safe for localized prostate cancer. Overall, the safety data for this treatment appears promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about brachytherapy for prostate cancer because it offers a highly targeted form of radiation therapy. Unlike traditional treatments, such as external beam radiation or surgery, brachytherapy involves implanting radioactive seeds directly into the prostate. This allows for a concentrated dose of radiation to the tumor with minimal impact on surrounding healthy tissues. Additionally, the procedure is relatively quick, lasting only 1-2 hours, and can be tailored based on the extent of cancer involvement, which may lead to fewer side effects and a faster recovery.

What evidence suggests that brachytherapy might be an effective treatment for prostate cancer?

Studies have shown that brachytherapy, which involves placing tiny radioactive seeds directly into the prostate, can effectively treat prostate cancer. Research indicates that patients treated with these seeds have a high chance of surviving without cancer recurrence. One study found that the 5-year survival rate for these patients was higher compared to other treatments. Another study suggested that this method is as effective as other types of radiation therapy in preventing cancer from returning. In this trial, participants will receive brachytherapy, with separate treatment arms for those with less than 35% biopsy core involvement and those with more than 35% biopsy core involvement. These findings suggest that brachytherapy is a strong option for managing prostate cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Steven J. Frank

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9098556/

The 45-month therapy outcomes of permanent seed ...

In prostate cancer patients, permanent seed implantation using iodine-125 seeds resulted in similar biochemical recurrence-free survival to ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1687850725002572

Meta-analysis of treatment effects for localized prostate ...

The effect of BT seed implantation in treating localized prostate cancer is better than that of EBRT. The 5-year overall survival rate of patients is higher.

3.

thegreenjournal.com

thegreenjournal.com/article/S0167-8140(23)89749-3/fulltext

The prognosis of patients with prostate cancer receiving ...

We study a relationship between prostate volume (PV) and prognosis in 6721 prostate cancer patients treated by permanent seed implantation (PI)

4.

emedicine.medscape.com

emedicine.medscape.com/article/453349-overview

Brachytherapy (Radioactive Seed Implantation Therapy) in ...

HDR combined with external beam radiotherapy was an effective and safe treatment for localized prostate cancer. Pelvic irradiation was suggested ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9953871/

A Contemporary Report of Low-Dose-Rate Brachytherapy ...

This study describes the outcomes of 149 men with prostate cancer treated at a single center with Iodine-125 low dose rate brachytherapy ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2287888223000041

The oncologic and safety outcomes of low-dose-rate ...

The 7-year biochemical progression-free survival of LDR brachytherapy was significantly higher than that of DE-EBRT both in intermediate- and high-risk patients ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6043740/

Low dose rate prostate brachytherapy - PMC

The long-term cause-specific survival (CSS) estimates exceeding 95% in all series further supports the curative nature of prostate cancer treatment with LDR ...