High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma

NCT04945642 | Recruiting DMC FDA Device

• 2 other identifiers: 21-000704NCI-2021-05623
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Conditions

Prostate Adenocarcinoma; Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• Biochemical failure

  Will be based on Phoenix criteria (either a rise of 2 ng/mL or more above nadir prostate specific antigen \[PSA\], or patients not meeting this criterion but underwent salvage therapies). The biochemical progression free survival (b-PFS) will be defined from the date of completing radiotherapy to the date biochemical failure, death, or last follow-up, stratified by prostate cancer risk classification. Kaplan-Meier method will be used.

  Up to 5 years

• Patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms

  Will be assessed on the Expanded Prostate Cancer Index-26 (EPIC-26) questionnaire.

  At 90 days

Secondary Outcomes (13)

• Patient-reported GU symptoms

  At end of radiotherapy, 6, 12, 24, and 60 months

• Patient-reported GI symptoms

  At end of radiotherapy, 6, 12, 24, and 60 months

• The acute grade >= 2 GU physician-scored toxicity

  Up to 90 days from treatment completion

• The acute grade >= 2 GI physician-scored toxicity

  Up to 90 days from treatment completion

• The late grade >= 2 GU physician-scored toxicity

  90 days from treatment completion, assessed up to 5 years

Study Arms (1)

Treatment (HDR-BT, SBRT)

EXPERIMENTAL

Patients undergo HDR-BT for up to 24 hours and undergo SBRT every other day or consecutive days for up to 14 consecutive chronologic days in the absence of disease progression or unacceptable toxicity.

Radiation: High-Dose Rate Brachytherapy; Radiation: Stereotactic Body Radiation Therapy

Interventions

High-Dose Rate Brachytherapy RADIATION

Undergo HDR-BT

Also known as: Brachytherapy, High Dose

Treatment (HDR-BT, SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (HDR-BT, SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand a written informed consent document, and the willingness to sign it
• Age \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
• Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7
• No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
• Prostate size =\< 60cc
• International Prognostic Scoring System (IPSS) score =\< 15
• Able to safely receive moderate sedation or general anesthesia

You may not qualify if:

• Patients with neuroendocrine or small cell carcinoma of the prostate
• Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
• Regional lymph node involvement
• Evidence of distant metastases
• Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer
• Previous pelvic irradiation or prostate brachytherapy
• Previous or concurrent cytotoxic chemotherapy for prostate cancer
• Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery
• Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California at Los Angeles / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stephanie M Yoon, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vince Basehart

CONTACT

310-267-8954; vbasehart@mednet.ucla.edu

Maria Casado

CONTACT

310-794-6913; mcasado@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 30, 2021
• Study Start: August 20, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)