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

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ClinicalTrials.gov Identifier: NCT04945642
Recruitment Status : Recruiting
First Posted : June 30, 2021
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Radiation: High-Dose Rate Brachytherapy Radiation: Stereotactic Body Radiation Therapy Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the biochemical progression-free survival (b-PFS) at the 5-year time point after combination therapy of stereotactic body radiotherapy (SBRT) and high dose rate (HDR)-brachytherapy (BT) boost stratified by patients with intermediate and high-risk prostate cancer.

II. To estimate the rate of acute >= grade 3 patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms determined within 90 days after treatment completion, respectively.

SECONDARY OBJECTIVES:

I. To estimate patient-reported GU symptoms at the end of radiotherapy and within 6, 12, 24, and 60 months from radiotherapy completion.

II. To estimate patient reported GI symptoms at the end of radiotherapy and within 6, 12, 24, and 60 months from radiotherapy completion.

III. To estimate the cumulative incidence of acute grade >= 2 GU physician-scored toxicity, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale.

IV. To estimate the cumulative incidence of acute grade >= 2 GI physician-scored toxicity, as assessed by the CTCAE version 5.0 scale.

V. To estimate the cumulative incidence of late >= 2 GU physician-scored toxicity, as assessed by the CTCAE version 5.0 scale.

VI. To estimate the cumulative incidence of late >= 2 GI physician-scored toxicity, as assessed by the CTCAE version 5.0 scale.

VII. To determine the prostate specific antigen (PSA) complete response rate (PSA nadir =< 0.3ng/mL) at 3 months following treatment of combination SBRT and HDR-BT boost regardless of testosterone recovery.

VIII. To determine clinical progression-free survival at 5-years. IX. To determine distant metastasis-free survival at 5-years. X. To determine overall survival at 5-years.

OUTLINE:

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.

After completion of study treatment, patients are followed up within 90 days, every 3 months for 24 months, and then every 6 months for up to 5 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)
Actual Study Start Date : August 20, 2021
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : July 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (HDR-BT, SBRT)
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
Undergo HDR-BT
Other Name: Brachytherapy, High Dose

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Biochemical failure [ Time Frame: Up to 5 years ]
    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.

  2. Patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms [ Time Frame: At 90 days ]
    Will be assessed on the Expanded Prostate Cancer Index-26 (EPIC-26) questionnaire.


Secondary Outcome Measures :
  1. Patient-reported GU symptoms [ Time Frame: At end of radiotherapy, 6, 12, 24, and 60 months ]
    Will be assessed on EPIC-26. EPIC assesses the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

  2. Patient-reported GI symptoms [ Time Frame: At end of radiotherapy, 6, 12, 24, and 60 months ]
    Will be assessed on EPIC-26. EPIC assesses the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

  3. The acute grade >= 2 GU physician-scored toxicity [ Time Frame: Up to 90 days from treatment completion ]
    Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  4. The acute grade >= 2 GI physician-scored toxicity [ Time Frame: Up to 90 days from treatment completion ]
    Will be assessed by CTCAE version 5.0.

  5. The late grade >= 2 GU physician-scored toxicity [ Time Frame: 90 days from treatment completion, assessed up to 5 years ]
    Will be assessed by CTCAE version 5.0.

  6. The late grade >= 2 GI physician-scored toxicity [ Time Frame: 90 days from treatment completion, assessed up to 5 years ]
    Will be assessed by CTCAE version 5.0.

  7. PSA complete response [ Time Frame: 3 months after treatment completion ]
    Will be defined as PSA =< 0.3 ng/mL three months after treatment completion.

  8. Clinical disease progression to any anatomical site [ Time Frame: Up to 5 years ]
    Will be based on patient history, physical examination, or imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET]).

  9. Clinical distant disease progression to anatomical sites outside prostate and regional lymph nodes [ Time Frame: Up to 5 years ]
    Will be based on imaging (CT, PET).

  10. Number of participants lost-to-follow-up [ Time Frame: Up to 5 years ]
    Number of deaths or patients lost-to follow-up during the follow-up period

  11. Progression-free survival [ Time Frame: Up to 5 years ]
    Will be estimated by the Kaplan-Meier method.

  12. Distant disease-free survival [ Time Frame: Up to 5 years ]
    Will be estimated by the Kaplan-Meier method.

  13. Overall survival [ Time Frame: Up to 5 years ]
    Will be estimated by the Kaplan-Meier method.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04945642


Contacts
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Contact: Vince Basehart 310-267-8954 vbasehart@mednet.ucla.edu
Contact: Maria Casado 310-794-6913 mcasado@mednet.ucla.edu

Locations
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United States, California
University of California at Los Angeles / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Vince M. Basehart    310-267-8954    vbasehart@mednet.ucla.edu   
Principal Investigator: Stephanie M. Yoon         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Stephanie M Yoon, MD University of California, Los Angeles
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04945642    
Other Study ID Numbers: 21-000704
NCI-2021-05623 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type