Recruiting
Phase 1
Phase 2

HDR-B

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT07182279

Conditions

Prostate Cancer (Adenocarcinoma)

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Brachytherapy

Study Details

Brief summary:

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Study ID

NCT07182279

Start date

Aug 1, 2025

Status verified date

Mar, 2026

Completion date

Nov 14, 2026

Anticipated

Primary completion date

Nov 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
2. Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
3. Subjects must have one of the following risk factors:

  • PSA ≥20 and/or
  • Gleason score ≥8 and/or
  • Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 8th Edition Staging Manual and/or
  • At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 4+3, clinical stage = T2b/T2c, ≥50% positive biopsy cores.
4. Subjects must freely sign informed consent to enroll in the study.
5. Subjects must be medically fit to undergo surgery and HDR-B as determined by the PI.
6. Age ≥ 40
7. ECOG Performance Status (performance status is an attempt to quantify cancer patients\' general well-being and activities of daily life, scores range from 0 to 5 where 0 represents perfect health and 5 represents death): 0-1.
8. No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
9. Subjects must not have had prior androgen deprivation therapy in the past 6 months.

Exclusion Criteria:

1. Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
2. Declared high-risk for anesthesia by attending cardiologist, or other physician.
3. History of prior pelvic radiation therapy.
4. Prostate gland \>70 cc as assessed by MRI or TRUS.
5. Baseline IPSS \>15 with medical optimization.
6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment).
7. Unwilling or unable to comply with the study protocol.

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Study Design

Enrollment

29 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Decipher < 0.85

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

active comparator: Decipher ≥0.85 with AAB

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.

Interventions

Brachytherapy

All patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Patients with high genomic risk or node positivity will receive short course adjuvant AAB.

Primary outcome measure

  • Incidence of Adverse Events [ Time Frame: up to two years post RALP ]
  • Treatment Completion [ Time Frame: up to two years post RALP ]

Central Contacts and Locations

Central contacts

Vivian MacDonnell, CCRP

713-441-8113vmmacdonnell@houstonmethodist.org

Andrew Fararch, MD

713-441-4800amfarach@houstonmethodist.org

Locations

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Andrew Farach, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • high risk prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-03-09.