High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-Dose Rate Brachytherapy, Stereotactic Body Radiation Therapy.
- Who it may be relevant to
- Registry 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. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)
Overview
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.
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.
Interventions
- Radiation High-Dose Rate Brachytherapy
Undergo HDR-BT - Radiation Stereotactic Body Radiation Therapy
Undergo SBRT
Primary outcome measures
- Biochemical failure [Time frame: Up to 5 years]
- Patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms [Time frame: At 90 days]
Secondary outcome measures (12)
- Patient-reported GU symptoms [Time frame: At end of radiotherapy, 6, 12, 24, and 60 months]
- Patient-reported GI symptoms [Time frame: At end of radiotherapy, 6, 12, 24, and 60 months]
- The acute grade >= 2 GU physician-scored toxicity [Time frame: Up to 90 days from treatment completion]
- The acute grade >= 2 GI physician-scored toxicity [Time frame: Up to 90 days from treatment completion]
- The late grade >= 2 GU physician-scored toxicity [Time frame: 90 days from treatment completion, assessed up to 5 years]
- The late grade >= 2 GI physician-scored toxicity [Time frame: 90 days from treatment completion, assessed up to 5 years]
- PSA complete response [Time frame: 3 months after treatment completion]
- Clinical disease progression to any anatomical site [Time frame: Up to 5 years]
- Clinical distant disease progression to anatomical sites outside prostate and regional lymph nodes [Time frame: Up to 5 years]
- Number of participants lost-to-follow-up [Time frame: Up to 5 years]
- Progression-free survival [Time frame: Up to 5 years]
- Distant disease-free survival [Time frame: Up to 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California at Los Angeles / Jonsson Comprehensive Cancer Center — Los Angeles
Identifiers
NCT: NCT04945642 · 21-000704 · NCI-2021-05623