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 is a Phase I/II trial evaluating the effectiveness of adding neoadjuvant HDR-B prior to RALP for HR-PCa patients with selective AAB for decipher high risk or pathologically node positive patients.

Patients with newly diagnosed, histologically confirmed, non-metastatic, HR-PCa who are scheduled to receive RALP will be eligible to participate in the study.

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+