Brachytherapy for Prostate Cancer

Overseen By Andrew Fararch, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Androgen deprivation therapy

Disqualifiers: Metastatic disease, High-risk anesthesia, Prior pelvic radiation, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating high-risk prostate cancer before surgery. It combines a special type of radiation therapy, called high dose rate brachytherapy, with prostate removal surgery to assess improvements in outcomes. Some patients will also receive additional hormone treatments if their cancer exhibits certain high-risk features. Men recently diagnosed with high-risk prostate cancer that hasn't spread and are scheduled for prostate surgery might be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have been on androgen deprivation therapy recently, you may need to stop, as the trial excludes those who have had it in the past 6 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high-dose-rate brachytherapy (HDR-B) is generally safe for treating prostate cancer. Studies indicate that HDR-B can safely and effectively increase radiation doses for men with intermediate and high-risk prostate cancer, with many patients tolerating the treatment well.

Although detailed side effects aren't listed in the sources, previous studies suggest HDR-B is a dependable option. It has been used successfully in other situations, indicating that patients usually manage the treatment well, though individual reactions can vary.

For patients with higher genetic risk, the study includes additional treatments with drugs that block male hormones and a type of hormone therapy. These treatments have already been approved for other uses, suggesting they are likely safe, though they may have side effects.

Overall, the data suggest this treatment approach is generally safe, but individual experiences may differ. Patients should always discuss potential risks and benefits with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the neoadjuvant high dose rate brachytherapy (HDR-B) for prostate cancer because it offers a unique approach compared to traditional treatments like surgery, external beam radiation, and hormone therapy. This treatment delivers a concentrated, single fraction of radiation directly to the prostate, potentially reducing the overall treatment time and minimizing exposure to surrounding healthy tissues. For patients with higher genomic risk, an additional innovative feature is the use of androgen receptor inhibitors and GnRH modulators, which target cancer growth more precisely and may improve outcomes. By combining targeted radiation with advanced hormonal therapy, this approach might enhance effectiveness and reduce side effects compared to current standard treatments.

What evidence suggests that neoadjuvant high dose rate brachytherapy might be an effective treatment for high-risk prostate cancer?

Research has shown that high-dose-rate (HDR) brachytherapy holds promise for treating prostate cancer. In this trial, participants will receive HDR brachytherapy as a single fraction. Studies have found that combining HDR brachytherapy with external beam radiation therapy (EBRT) leads to excellent rates of preventing cancer recurrence. This combination reduces the likelihood of cancer returning after treatment. Adding hormone therapy, which lowers male hormone levels, can further improve long-term survival. HDR brachytherapy is also expected to control cancer as effectively as traditional low-dose-rate brachytherapy. Overall, HDR brachytherapy appears to manage prostate cancer effectively, helping patients remain cancer-free longer. ^{1 2 4 6 7}

Who Is on the Research Team?

Andrew Farach, MD

Principal Investigator

The Methodist Hospital Reseach Institute

Are You a Good Fit for This Trial?

This trial is for patients with newly diagnosed, non-metastatic high-risk prostate cancer (HR-PCa) who are scheduled for a robotic-assisted radical prostatectomy (RALP). It's specifically aimed at those identified as high risk by certain tests or found to have cancer in their lymph nodes.

Inclusion Criteria

Subjects must freely sign informed consent to enroll in the study

My prostate cancer was confirmed by a biopsy.

My scans show no signs of cancer spread to bones or other areas.

Exclusion Criteria

Declared high-risk for anesthesia by attending cardiologist, or other physician

Unwilling or unable to comply with the study protocol

My cancer has spread, confirmed by a scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant HDR-B

Participants receive a single fraction of high dose rate brachytherapy (15Gy) prior to robotic assisted laparoscopic prostatectomy

4-8 weeks

Robotic Assisted Laparoscopic Prostatectomy (RALP)

Participants undergo RALP surgery following HDR-B treatment

1 day

Adjuvant Androgen Blockade (AAB)

Participants with high genomic risk or node-positive disease receive adjuvant androgen blockade therapy

12 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life post-treatment

up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Neoadjuvant High Dose Rate Brachytherapy

Trial Overview The study is testing the effectiveness of adding a treatment called High Dose Rate Brachytherapy (HDR-B) before the standard RALP surgery. This approach is being evaluated in Phase I/II to see if it improves outcomes for these high-risk patients.

How Is the Trial Designed?

Group I: Decipher < 0.85 Active Control 1 Intervention

Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP.

Group II: Decipher ≥0.85 with AAB Active Control 1 Intervention

Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. In addition, patients with high genomic risk (≥0.85) will receive AAB for 12 weeks in the adjuvant setting beginning 8 weeks post RALP. Patients will receive an androgen receptor inhibitor per treating physician discretion (darolutamide 600 mg PO BID, enzalutamide 160 mg PO QD, apalutamide 240 mg PO QD, or bicalutamide 50 mg PO QD). In addition, patients will receive either a GnRH antagonist (relugolix 360 mg PO x 1 day followed by 120 mg PO QD) or a GnRH agonist (leuprolide 22.5 mg SC once or goserelin 10.8 mg SC once). Pathologically node positive patients will receive adjuvant pelvic radiation therapy as is SOC once the patient has recovered from surgery.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12190164/

Long-Term Outcomes After High-Dose-Rate Brachytherapy ... These outcomes included lower biochemical recurrence-free survival at 5 and 8 years, lower OS, and lower prostate CSS compared to patients with ...

2. nature.com nature.com/articles/s41598-025-89771-x

Biochemical response to neoadjuvant hormonal therapy ... Biochemical response to neoadjuvant hormonal therapy predicts long-term prostate cancer survival outcomes after high-dose-rate brachytherapy ...

3. link.springer.com link.springer.com/article/10.1007/s11604-024-01621-4

Long-term outcomes of high-dose-rate brachytherapy and ... Biochemical response to neoadjuvant hormonal therapy predicts long-term prostate cancer survival outcomes after high-dose-rate brachytherapy ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1538472112001663

Clinical outcomes of high-dose-rate brachytherapy and ... Conclusion. HDR prostate brachytherapy in conjunction with supplemental EBRT results in excellent biochemical relapse-free survival rates with a low incidence ...

5. brachyjournal.com brachyjournal.com/article/S1538-4721(25)00117-5/fulltext

High-dose-rate (HDR) brachytherapy boost in combination ... HDR brachytherapy boost is expected to achieve similar biochemical control outcomes as a low dose rate (LDR) brachytherapy boost. Androgen deprivation therapy ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1538472125001175

High-dose-rate (HDR) brachytherapy boost in combination ... CONCLUSIONS. For men with intermediate- and high-risk prostate cancer, HDR brachytherapy boost is a safe and effective technique for dose-escalation that can ...

7. vvh.org vvh.org/documents/Rossi-2025-Publication_High-Dose-Rate.HDR)-Brachytherapy-Boost.pdf

High-dose-rate (HDR) brachytherapy boost in combination ... EBRT plus brachytherapy, can provide benefits in long- term outcomes in patients with intermediate and high- risk prostate cancer. The landmark ASCENDE-RT trial.