Focal Brachytherapy for Prostate Cancer

Overseen By Daniel Song, MD

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Pelvic radiation, Major illness, Implants, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating prostate cancer using focal brachytherapy, a type of internal radiation therapy. The goal is to use advanced imaging to target only significant cancerous areas, minimizing exposure to healthy regions and reducing side effects. Suitable candidates for this trial include men diagnosed with prostate cancer that hasn't spread, with specific cancer characteristics and a prostate size under 60cc. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that focal brachytherapy is safe for prostate cancer?

Research has shown that focal brachytherapy is generally safe for treating prostate cancer. Studies have found it effective for patients with low- or intermediate-risk prostate cancer. Most patients manage the side effects well, allowing them to undergo treatment without serious issues.

Both low-dose and high-dose brachytherapy options have been well-tolerated by patients, showing good results with limited harmful effects. This suggests that focal brachytherapy, which targets specific cancer areas, is also likely to be well-tolerated.

In this trial, imaging techniques help focus the treatment, potentially reducing side effects further. This approach may enhance safety compared to traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Focal brachytherapy is unique because it uses a precise, targeted approach to treat prostate cancer, minimizing damage to surrounding healthy tissue. Unlike traditional treatments like radical prostatectomy or external beam radiation, which can affect a larger area, focal brachytherapy delivers radiation directly to the cancerous part of the prostate. Researchers are excited about this treatment because it incorporates PSMA PET imaging, which provides high-resolution images to better guide the radiation, potentially improving accuracy and outcomes while reducing side effects.

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

Research has shown that focal brachytherapy, which participants in this trial will receive, is a promising treatment for prostate cancer that hasn't spread. It is safe and effective for patients with low- or intermediate-risk prostate cancer. This treatment uses precise radiation to target and shrink tumors while protecting nearby healthy tissue. Studies have demonstrated excellent results in controlling cancer with this method. Additionally, advanced imaging techniques like PSMA PET, included in this trial, help better identify important tumors, reducing unnecessary exposure and potential side effects. ^{1 2 3 5 6}

Who Is on the Research Team?

Daniel Y. Song

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Men with prostate cancer can join this trial if they have a specific type of tumor (adenocarcinoma), are in fairly good health, and their cancer hasn't spread far. Their prostate must be below a certain size, and they need to be able to handle a special PET scan. They can't participate if they've had pelvic radiation before or other major illnesses that could affect the treatment.

Inclusion Criteria

I have been diagnosed with prostate adenocarcinoma.

You have mild to moderate urinary symptoms, with a score of 20 or less on the International Prostate Symptom Score (IPSS) questionnaire.

Prostate volume < 60 cc (if MRI and TRUS have conflicting values, then MRI value will be utilized)

Exclusion Criteria

Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.

You have metal implants in your body or have a fear of small spaces that cannot be treated with medication. You also have a medical condition that makes it unsafe for you to have an MRI scan.

You have an implanted device that makes it difficult to see internal structures during imaging.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo focal brachytherapy with PSMA PET imaging using 18F-DCFPyl to target clinically significant tumors

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with tumor volume coverage assessed on Day 30 post-implant

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• (18F)DCFPyL
• Focal Brachytherapy

Trial Overview The study is testing focal brachytherapy guided by an advanced imaging technique using PSMA PET scans. The goal is to target only significant tumors while reducing damage to healthy areas, potentially lowering side effects.

How Is the Trial Designed?

Group I: Focal brachytherapy Experimental Treatment 2 Interventions

Drug: 18F-DCFPyl Other names: PET, PSMA Procedure: Focal brachytherapy with PSMA PET imaging Other names: Radiotherapy, Radiation, Prostate seed implant, Focal therapy

Focal 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
• Uterine cancer
• Breast cancer

Approved in European Union as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Uterine cancer
• Breast cancer
• Esophageal cancer
• Lung cancer

Approved in Canada as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Uterine cancer
• Breast cancer

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

Low dose rate (LDR) permanent seed brachytherapy is an effective treatment option for low-risk and favorable intermediate-risk prostate cancer, and it can also be used as a boost in combination with external beam radiation for unfavorable intermediate and high-risk cases.

While LDR brachytherapy can lead to increased urinary symptoms initially, these typically resolve within 6 to 12 months, and the treatment is generally well-tolerated, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low dose rate brachytherapy for primary treatment of localized prostate cancer: A systemic review and executive summary of an evidence-based consensus statement. King, MT., Keyes, M., Frank, SJ., et al.[2022]

In a Phase II trial involving 101 patients with prostate cancer, focal dose escalation using brachytherapy showed low late toxicity, with only 4% of patients experiencing significant urinary side effects and no severe rectal toxicities reported.

The treatment demonstrated high efficacy, with a 5-year local recurrence rate of just 1% and biochemical disease-free survival rates of 98.1% for low-/intermediate-risk patients and 81.3% for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brachytherapy focal dose escalation using ultrasound based tissue characterization by patients with non-metastatic prostate cancer: Five-year results from single-center phase 2 trial. Strnad, V., Lotter, M., Kreppner, S., et al.[2022]

Focal low-dose-rate (LDR) prostate brachytherapy for low- and intermediate-risk prostate cancer showed a high 2-year biochemical recurrence-free rate of 92.9% among 19 patients, indicating its efficacy as a treatment option.

The treatment was associated with minimal toxicity, as no patients experienced significant gastrointestinal issues and only two had temporary urinary frequency, suggesting it is a safe and feasible minimally invasive approach for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal low-dose-rate prostate brachytherapy for low- and intermediate-risk prostate cancer. Kunogi, H., Wakumoto, Y., Kawamoto, T., et al.[2022]

The study evaluated the learning curve of permanent interstitial brachytherapy for prostate cancer in 38 patients, showing that after treating 18 patients, the technique stabilized with significant improvements in the D90 post-implant dose, indicating better treatment quality.

Factors such as accurate seed positioning and precise organ volume definition on post-implant imaging were crucial for improving implantation quality, as evidenced by the increase in D90 post values from 79.3% in the first group to 99.9% in the third group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of dose-volume histograms after prostate seed implantation. 4-year experience. Hoinkis, C., Hakenberg, OW., Lehmann, D., et al.[2019]

Focal brachytherapy for prostate cancer aims to effectively target only the cancerous areas, potentially reducing side effects like genitourinary and rectal complications compared to whole gland treatment.

A consensus meeting of international experts has established guidelines for patient selection, treatment protocols, and follow-up for focal brachytherapy, paving the way for future clinical trials to evaluate its effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Report of a consensus meeting on focal low dose rate brachytherapy for prostate cancer. Langley, S., Ahmed, HU., Al-Qaisieh, B., et al.[2023]

Focal prostate brachytherapy has the potential to effectively target cancer while reducing radiation exposure to surrounding healthy organs, which may allow for future salvage treatments if needed.

The review of 9 dosimetric and 6 clinical studies indicates that focal brachytherapy results in less toxicity compared to traditional whole gland treatments, suggesting it could be a safer option for patients with prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Focal Prostate Brachytherapy and the Future Implementation of Image-Guided Prostate HDR Brachytherapy Using MR-Ultrasound Fusion. Peach, MS., Trifiletti, DM., Libby, B.[2022]

In a study of 26 men with low to intermediate risk prostate cancer, focal low dose-rate (LDR) brachytherapy showed a high rate of biochemical control, with 96.2% of patients free from biochemical failure after treatment.

The treatment had a favorable safety profile, with only 29.2% experiencing grade 2 urinary toxicities and 45.8% reporting erectile toxicities, all of which resolved by the last follow-up, and no severe toxicities reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal low dose-rate brachytherapy for low to intermediate risk prostate cancer: preliminary experience at an Australian institution. Anderson, E., Smyth, LML., O'Sullivan, R., et al.[2022]

In a study involving five prostate cancer patients, the loss of brachytherapy seeds through the urethra resulted in a modest reduction in the dose delivered to the tumor (D(90) reduction of 2% to 7% depending on the number of seeds lost).

Despite the reduction in dose coverage due to seed loss, the study found that this did not significantly impact the tumor control probability, suggesting that the treatment remains effective even with some seed migration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the dosimetric and tumor control consequences of prostate seed loss and migration. Knaup, C., Mavroidis, P., Esquivel, C., et al.[2021]

Focal low-dose-rate brachytherapy (LDR-PB) for prostate cancer was shown to be feasible in a small study of five patients, with promising short-term outcomes and a favorable side effect profile compared to standard treatments.

Multi-parametric MRI (mpMRI) demonstrated low sensitivity for detecting tumors but showed potential for identifying higher-grade cancers, suggesting it could be a useful screening tool for selecting candidates for focal LDR-PB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal application of low-dose-rate brachytherapy for prostate cancer: a pilot study. Mahdavi, SS., Spadinger, IT., Salcudean, SE., et al.[2020]

In a phase II study involving 17 patients, low-dose-rate ultrafocal brachytherapy successfully delivered over 95% of the prescribed dose to the targeted prostate cancer area, demonstrating its feasibility for precise treatment.

The treatment resulted in minimal side effects, with negligible urethral and rectal toxicity, and no cancer recurrence was observed in the treated area after one year, indicating both safety and efficacy of this targeted approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IDEAL 2a Phase II Study of Ultrafocal Brachytherapy for Low- and Intermediate-risk Prostate Cancer. Graff, P., Portalez, D., Lusque, A., et al.[2019]

Citations

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

Low dose rate prostate brachytherapy - PMC Low dose rate (LDR) prostate brachytherapy is an evidence based radiation technique with excellent oncologic outcomes. By utilizing direct image guidance ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850021000011

Focal Brachytherapy for Localized Prostate Cancer Conclusions. F-BT is a safe and effective treatment for selected patients presenting with low- or intermediate-risk localized prostate cancer.

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00651-0/fulltext

Prostate high dose-rate brachytherapy as monotherapy for ... We report on the efficacy of a randomized Phase II trial comparing HDR monotherapy delivered as 27 Gy in 2 fractions vs. 19 Gy in 1 fraction with a median ...

4. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00148-4/fulltext

High-Dose-Rate Brachytherapy Boost for Prostate Cancer However, studies have shown that combining brachytherapy with EBRT results in a higher rate of cancer control than EBRT alone. Nevertheless, the ...

5. americanbrachytherapy.org americanbrachytherapy.org/ABS/document-server/?cfp=ABS/assets/File/public/consensus-statements/1-s2_0-S1538472121004566-main.pdf

Low dose rate brachytherapy for primary treatment of ... For Gleason 9–10 prostate cancer, Kishan et al. reported that trimodality therapy (ADT, EBRT, and brachytherapy boost) was associated with better PCSM and ...

6. mdpi.com mdpi.com/2075-4426/14/8/882

Outcomes of I-125 Low-Dose-Rate Brachytherapy in ... LDR brachytherapy in patients with prostate cancer is an effective treatment, with favorable clinical outcomes and manageable toxicity.