RECRUITING

Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

High Dose Rate Brachytherapy Prior to Robotic Assisted Laparoscopic Prostatectomy With Selective Adjuvant Androgen Blockade for Localized High-risk Prostate Cancer (NEOHDR-B)

Quick Facts

Study Start:2025-08-01
Study Completion:2026-11-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07182279

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
  2. 2. Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
  3. 3. Subjects must have one of the following risk factors:
  4. * PSA ≥20 and/or
  5. * Gleason score ≥8 and/or
  6. * Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 8th Edition Staging Manual and/or
  7. * 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.
  8. 4. Subjects must freely sign informed consent to enroll in the study.
  9. 5. Subjects must be medically fit to undergo surgery and HDR-B as determined by the PI.
  10. 6. Age ≥ 40
  11. 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.
  12. 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.
  13. 9. Subjects must not have had prior androgen deprivation therapy in the past 6 months.
  1. 1. Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
  2. 2. Declared high-risk for anesthesia by attending cardiologist, or other physician.
  3. 3. History of prior pelvic radiation therapy.
  4. 4. Prostate gland \>70 cc as assessed by MRI or TRUS.
  5. 5. Baseline IPSS \>15 with medical optimization.
  6. 6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment).
  7. 7. Unwilling or unable to comply with the study protocol.

Contacts and Locations

Study Contact

Vivian MacDonnell, CCRP
CONTACT
713-441-8113
vmmacdonnell@houstonmethodist.org
Andrew Fararch, MD
CONTACT
713-441-4800
amfarach@houstonmethodist.org

Principal Investigator

Andrew Farach, MD
PRINCIPAL_INVESTIGATOR
The Methodist Hospital Reseach Institute

Study Locations (Sites)

Houston Methodist
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

  • Andrew Farach, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Reseach Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2026-11-14

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2026-11-14

Terms related to this study

Keywords Provided by Researchers

  • high risk prostate cancer

Additional Relevant MeSH Terms

  • Prostate Cancer (Adenocarcinoma)