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

Trial Summary

What is the purpose of this trial?

The Principal Investigator's (PI) working hypothesis is that the PI can utilize the high predictive value of 18F-DCFPyl PSMA to identify clinically significant tumors in patients who will undergo brachytherapy, as well as areas which are uninvolved or contain only clinically insignificant disease. In the PI's clinical trial, the uninvolved regions (as defined by combined PET-MR-biopsy data) will not be targeted and receive only fall-off dose, which we have shown to be associated with reductions in toxicity.

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

Research shows that focal low-dose-rate brachytherapy is effective for treating localized prostate cancer, providing good cancer control with fewer side effects compared to whole gland treatments. It is particularly beneficial for low-risk patients, offering a lower chance of erectile dysfunction and urinary incontinence than surgery. ^{1 2 3 4 5}

Is focal brachytherapy for prostate cancer safe for humans?

Research suggests that focal brachytherapy for prostate cancer can reduce the dose to nearby organs and result in less toxicity (harmful side effects) compared to treating the whole prostate gland. This indicates it may be a safer option for patients. ^{3 6 7 8 9}

How is focal brachytherapy different from other prostate cancer treatments?

Focal brachytherapy is unique because it targets only the cancerous areas of the prostate with low-dose radiation, aiming to control the cancer while minimizing side effects to surrounding tissues. This approach is different from whole gland treatments, as it combines precise targeting with ongoing monitoring of the unaffected prostate areas. ^{1 2 3 10 11}

Research Team

Daniel Y. Song

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

Focal low dose-rate brachytherapy for low to intermediate risk prostate cancer: preliminary experience at an Australian institution. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Report of a consensus meeting on focal low dose rate brachytherapy for prostate cancer. [2023]

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

Focal low-dose-rate prostate brachytherapy for low- and intermediate-risk prostate cancer. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of dose-volume histograms after prostate seed implantation. 4-year experience. [2019]

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

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

6. Egypt 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. [2022]

7. United States 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. [2022]

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

Investigating the dosimetric and tumor control consequences of prostate seed loss and migration. [2021]

9. United States 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. [2022]

10. Poland pubmed.ncbi.nlm.nih.gov

Focal application of low-dose-rate brachytherapy for prostate cancer: a pilot study. [2020]

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

IDEAL 2a Phase II Study of Ultrafocal Brachytherapy for Low- and Intermediate-risk Prostate Cancer. [2019]