What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including LDR brachytherapy, radical prostatectomy, and external beam radiation therapy (RT), have distinct side effects. LDR brachytherapy can cause urinary symptoms like urgency and frequency, and sexual dysfunction. Radical prostatectomy often results in significant sexual dysfunction and urinary incontinence, with some symptoms persisting for years. External beam RT can lead to bowel issues such as urgency and frequency, and sexual dysfunction, with some symptoms lasting for years. Combining RT with hormonal therapy may reduce the discrepancy between expected and experienced sexual side effects.

What prior FDA approvals exist?

The FDA has approved several advanced imaging and targeted radiation therapies for prostate cancer. One notable approval is for Ga-68 PSMA-11 (gozetotide) for PSMA-targeted PET imaging, which helps in precise detection of prostate cancer recurrence and metastases. Additionally, lutetium Lu 177 vipivotide tetraxetan has been approved for PSMA-positive metastatic castration-resistant prostate cancer, offering targeted radioligand therapy. These treatments leverage advanced imaging techniques to enhance the precision and effectiveness of radiation therapy, aligning with the goals of MR fusion 3D Ultrasound guided Low dose rate (LDR) brachytherapy.

What other types of research exist?

Promising alternatives to MR fusion 3D Ultrasound guided LDR brachytherapy for prostate cancer patients include: 1) High-Dose-Rate (HDR) brachytherapy, which offers precise radiation delivery and shorter treatment times. 2) Stereotactic Body Radiotherapy (SBRT), known for its high precision and fewer treatment sessions. 3) Radium-223, an alpha particle-emitting radiopharmaceutical that targets bone metastases and improves overall survival. 4) Lutetium-177-PSMA-617, a radioligand therapy targeting prostate-specific membrane antigen (PSMA) for metastatic castration-resistant prostate cancer. These alternatives provide targeted treatment with potential for better outcomes and reduced side effects.

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Brachytherapy

LDR Brachytherapy for Prostate Cancer (PRIAPUS Trial)

N/A

Recruiting

Led By Lucas Mendez, MD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-confirmed adenocarcinoma of the prostate

No contraindications to prostate LDR brachytherapy

Must not have

NCCN-defined unfavourable intermediate or high-risk prostate cancer

Core positivity in both lobes of the prostate with no DIL detected on mpMR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until study completion with 5 years of follow up

Awards & highlights

Summary

This trial is testing a new internal radiation treatment for prostate cancer that uses advanced imaging to precisely target the cancer. It aims to reduce erectile dysfunction by avoiding damage to nearby nerves and blood vessels. The treatment is designed for patients with prostate-confined cancers.

Who is the study for?

Men with biopsy-confirmed prostate cancer, where the disease is contained in one lobe of the prostate. They should have good erectile function and be sexually active, without severe urinary symptoms or any prior high-risk treatments for prostate cancer. Participants must be fit for anesthesia, under 75 years old, and not have inflammatory bowel disease or certain other medical conditions.

What is being tested?

The trial is testing a new way to do LDR brachytherapy that uses MR fusion with 3D Ultrasound guidance. The goal is to treat prostate cancer while sparing important nerves and vessels near the prostate and penile bulb to preserve sexual function.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, temporary urinary issues like frequency or urgency, erectile dysfunction risks due to nerve damage during treatment, as well as typical risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer was confirmed by a biopsy.

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I have no health issues preventing prostate seed implant therapy.

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My prostate cancer is considered low or favorable intermediate risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer is at an intermediate or high risk level.

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My prostate cancer is present in both lobes without aggressive features on MRI.

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I have had radiation therapy to my pelvis before.

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My MRI shows cancer spread beyond the prostate capsule or to the seminal vesicles.

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My MRI shows signs of cancer in both lobes of my prostate.

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I cannot undergo general or spinal anesthesia due to health reasons.

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My cancer has spread to distant parts of my body and/or lymph nodes.

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I am over 75 years old.

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I have had a prostate surgery known as TURP.

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I have had surgery to remove the rectum and anus.

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I have inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until study completion with 5 years of follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until study completion with 5 years of follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and until study completion with 5 years of follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of patients receiving this experimental brachytherapy technique and achieving acceptable dose distribution at 1-month post-implant.

Secondary study objectives

Acute and long-term GU and GI toxicity

Biochemical failure

Local recurrence

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prostate Cancer PatientsExperimental Treatment1 Intervention

Low- or favourable intermediate-risk prostate cancer patients

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include surgery, radiation therapy, hormone therapy, and focal therapies like brachytherapy. MR fusion 3D Ultrasound guided Low dose rate (LDR) brachytherapy uses advanced imaging techniques to precisely place radioactive seeds within the prostate, delivering targeted radiation to cancer cells while sparing surrounding healthy tissue. This precision reduces side effects and improves the quality of life for patients. Accurate imaging and targeted radiation are crucial as they enhance treatment efficacy and minimize damage to critical structures such as the neurovascular bundles and penile bulb, which are important for maintaining urinary and sexual function.

Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.Improving prostate cancer care collaboratively - a multidisciplinary, formal, consensus-based approach.Supporting prostate cancer focal therapy: a multidisciplinary International Consensus of Experts ("ICE").