Prostate AdenocarcinomaHYDRANCT04945642
High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma
A study testing High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in people with Prostate Adenocarcinoma and Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage IIC Prostate Cancer AJCC v8
- What is being tested?
- High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Prostate size =< 60cc
- International Prognostic Scoring System (IPSS) score =< 15
- Able to safely receive moderate sedation or general anesthesia
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California at Los Angeles / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Vince M. Basehart, 310-267-8954, vbasehart@mednet.ucla.edu
Stephanie M. Yoon
About this study
Official title: Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- 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
- Being tested
- High-Dose Rate Brachytherapy, Stereotactic Body Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose Rate BrachytherapyRadiation
Also called Brachytherapy, High Dose
Undergo HDR-BT
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: High-Dose Rate Brachytherapy; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 90 days
Secondary outcomes (13)
Patient-reported GU symptoms
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.
Measured: At end of radiotherapy, 6, 12, 24, and 60 months
Patient-reported GI symptoms
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.
Measured: At end of radiotherapy, 6, 12, 24, and 60 months
The acute grade >= 2 GU physician-scored toxicity
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 90 days from treatment completion
The acute grade >= 2 GI physician-scored toxicity
Will be assessed by CTCAE version 5.0.
Measured: Up to 90 days from treatment completion
The late grade >= 2 GU physician-scored toxicity
Will be assessed by CTCAE version 5.0.
Measured: 90 days from treatment completion, assessed up to 5 years
The late grade >= 2 GI physician-scored toxicity
Will be assessed by CTCAE version 5.0.
Measured: 90 days from treatment completion, assessed up to 5 years
PSA complete response
Will be defined as PSA =< 0.3 ng/mL three months after treatment completion.
Measured: 3 months after treatment completion
Clinical disease progression to any anatomical site
Will be based on patient history, physical examination, or imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET]).
Measured: Up to 5 years
Clinical distant disease progression to anatomical sites outside prostate and regional lymph nodes
Will be based on imaging (CT, PET).
Measured: Up to 5 years
Number of participants lost-to-follow-up
Number of deaths or patients lost-to follow-up during the follow-up period
Measured: Up to 5 years
Progression-free survival
Will be estimated by the Kaplan-Meier method.
Measured: Up to 5 years
Distant disease-free survival
Will be estimated by the Kaplan-Meier method.
Measured: Up to 5 years
Overall survival
Will be estimated by the Kaplan-Meier method.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start20 Aug 2021
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie M Yoon, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945642
- Sponsor's protocol ID
- 21-000704
- Other IDs
- NCI-2021-05623
- Acronym
- HYDRA
- Status last verified
- Aug 2026
- First submitted
- 14 Jun 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)
- ClinicalTrials.gov ID
- NCT04945642
- Acronym / sponsor ID
- HYDRA / 21-000704
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (HDR-BT, SBRT) | Experimental | Radiation: High-Dose Rate Brachytherapy, Radiation: Stereotactic Body Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Dose Rate BrachytherapyAlso: Brachytherapy, High DoseUndergo HDR-BT | Radiation | Treatment (HDR-BT, SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Treatment (HDR-BT, SBRT) |
Primary outcome
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.
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.
13 secondary outcomes
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
Overall survival
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie M Yoon, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in people with Prostate Adenocarcinoma and Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vince Basehart (310-267-8954, vbasehart@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical failure (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.