Prostate AdenocarcinomaNCT02346253
High-Dose Brachytherapy in Treating Patients With Prostate Cancer
A study testing Internal Radiation Therapy, Bicalutamide and Leuprolide Acetate in people with Prostate Adenocarcinoma and Stage I Prostate Cancer, run by Stanford University at 1 site in United States.
Trial summary
This trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer
- What is being tested?
- Internal Radiation Therapy, Bicalutamide and Leuprolide Acetate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2015to 17 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented pathologic confirmation of prostate adenocarcinoma
- Clinical T-classification T1-3
- PSA < 150 ng/mL
- Gleason score 6-10
- Clinically negative lymph nodes as established by abdomino-pelvic CT. CT only for clinical classification of T3 (with contrast if renal function is acceptable; a non-contrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection. Patients with lymph nodes equivocal or questionable by imaging are eligible if those nodes are <1 cm in short axis diameter. [56]
- No evidence of bone metastases (M0) on bone scan, only for PSA >20 ng/mLor Gleason ≥8, (NaF PET/CT is an acceptable substitute). Equivocal bone scan findings are allowed if plain films and/or MRI are negative for definite metastases.
- American Urological Association Symptom Index (AUA SI) =< 20
Who cannot join
- Clinical T4 disease
- PSA >= 150 ng/mL
- AUA SI > 20
- History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for prostate cancer
- Previous chemotherapy for any malignancy, if given within three years of registration
- History of rectal surgery
Show all 11Show fewer
- History of rectal fistula
- History of inflammatory bowel disease
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last six months
- Transmural myocardial infarction within the last six months
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
This trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a better treatment in patients with prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
To estimate the rate of acute (within 6 months of high-dose rate [HDR] completion) grade ≥ 2 genitourinary (GU) toxicity following high-dose-rate (HDR) brachytherapy (BT) as monotherapy for newly-diagnosed prostate cancer using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3 (CTCAE v3.0).
SECONDARY OBJECTIVES:
- Estimate the proportion of men with a prostate-specific antigen (PSA) nadir by one year (nPSA12) of < 2 ng/mL.
- Estimate the rate of freedom from biochemical failure at 5 years (FFBF).
- Evaluate patient-reported quality of life via the 32-item Expanded Prostate Cancer Index Composite (EPIC).
- Assess the cost-effectiveness of HDR BT as monotherapy for prostate cancer using the 6-item European Quality of Life 5-Dimensions (EQ-5D).
- Explore pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer.
- Compare acute and late (> 6 months after HDR completion) GU and gastrointestinal (GI) grade ≥ 2 toxicity using CTCAE v3.0 and v4.0.
- Explore dosimetric predictors of toxicity.
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients may receive androgen deprivation therapy (ADT) comprising bicalutamide orally (PO) once daily (QD). Patients may also receive luteinizing hormone-releasing hormone (LHRH) agonist therapy comprising leuprolide acetate intramuscularly (IM) or subcutaneously (SC), goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4 to 6 months (intermediate-risk patients receiving ADT) or 6 to 36 months (high-risk patients) at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and then yearly for up to 5 years.
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Being tested
- Internal Radiation Therapy, Bicalutamide, Leuprolide Acetate, Goserelin Acetate, Triptorelin Pamoate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Radiation TherapyRadiation
Also called Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy
Undergo high-dose-rate brachytherapy
BicalutamideDrug
Also called CDX
Given PO
Leuprolide AcetateDrug
Also called A-43818
Given IM or SC
Goserelin AcetateDrug
Also called ICI-118630, ZDX, Zoladex
Given SC
Triptorelin PamoateDrug
Also called Pamorelin, Trelstar
Given IM
DegarelixDrug
Also called FE200486, Firmagon
Given SC
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) | Experimental | Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician. Receives: Radiation: Internal Radiation Therapy; Drug: Bicalutamide; Drug: Leuprolide Acetate; Drug: Goserelin Acetate; Drug: Triptorelin Pamoate; Drug: Degarelix; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Measured: Within 6 months of HDR completion
Secondary outcomes (10)
Proportion of men with a nPSA12 of < 2 ng/mL
nPSA12 is defined as the lowest PSA level achieved during the first year after completing HDR.
Measured: Up to 1 year after completion of HDR
FFBF (Biochemical failure define according to PSA nadir+2ng/mL and 3 consecutive rises definition according to American Society of Radiation Oncology
Biochemical failure (BF) will be defined according the PSA nadir + 2 ng/mL and three consecutive rises definition according to the American Society of Radiation Oncology consensus recommendation. Time to first BF will be analyzed with competing risk models with death as a competing risk.
Measured: From the completion of all treatment to the time of BF, assessed at 5 years
Change in Quality of Life as Measured by Expanded Prostate Cancer Index Composite (EPIC) Scores
The Expanded Prostate Cancer Index Composite (EPIC) is a patient-reported health-related quality of life questionnaire that evaluates urinary, bowel, sexual, and hormonal function and bother among patients undergoing treatment for prostate cancer. Higher scores indicate better health-related quality of life within each domain.
Measured: Baseline to up to 5 years
Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores
Measured utility values for each patient on this study will be combined with overall survival to calculate the "QALY" quality-adjusted life years.
Measured: Up to 5 years
Pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer (association between each risk factor and the risk of having a first BF)
Clinical risk factors will be tested in competing risk models to evaluate the association between each risk factor and the risk of having a first BF.
Measured: Baseline
Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v4.0
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Measured: Within 6 months of HDR completion
Late GU toxicity, scored according to CTCAE v3.0 and v4.0
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Measured: Up to 5 years
Acute GI toxicity scored according to CTCAE v3.0 and CTCAE v4.0
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Measured: Up to 6 months after completing HDR BT
Late GI toxicity, scored according to CTCAE v3.0 and CTCAE v4.0
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Measured: Up to 5 years
Dosimetric predictors of toxicity (Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes)
Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes.
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 posted26 Jan 2015 (estimated)
- Study start13 Jan 2015
- Primary completion14 Dec 2021
- Study completion17 May 2026
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 Stanford UniversityThe 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Buyyounouski, Stanford University
- Investigators
- Mark Buyyounouski, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346253
- Sponsor's protocol ID
- IRB-32058
- Other IDs
- NCI-2015-00089, PROS0065
- Status last verified
- Jun 2026
- First submitted
- 20 Jan 2015
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02346253
- Acronym / sponsor ID
- IRB-32058
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 13 Jan 2015 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 17 May 2026 (actual)
- First posted
- 26 Jan 2015 (estimated)
- 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 trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a better treatment in patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
To estimate the rate of acute (within 6 months of high-dose rate [HDR] completion) grade ≥ 2 genitourinary (GU) toxicity following high-dose-rate (HDR) brachytherapy (BT) as monotherapy for newly-diagnosed prostate cancer using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3 (CTCAE v3.0).
SECONDARY OBJECTIVES:
- Estimate the proportion of men with a prostate-specific antigen (PSA) nadir by one year (nPSA12) of < 2 ng/mL.
- Estimate the rate of freedom from biochemical failure at 5 years (FFBF).
- Evaluate patient-reported quality of life via the 32-item Expanded Prostate Cancer Index Composite (EPIC).
- Assess the cost-effectiveness of HDR BT as monotherapy for prostate cancer using the 6-item European Quality of Life 5-Dimensions (EQ-5D).
- Explore pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer.
- Compare acute and late (> 6 months after HDR completion) GU and gastrointestinal (GI) grade ≥ 2 toxicity using CTCAE v3.0 and v4.0.
- Explore dosimetric predictors of toxicity.
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients may receive androgen deprivation therapy (ADT) comprising bicalutamide orally (PO) once daily (QD). Patients may also receive luteinizing hormone-releasing hormone (LHRH) agonist therapy comprising leuprolide acetate intramuscularly (IM) or subcutaneously (SC), goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4 to 6 months (intermediate-risk patients receiving ADT) or 6 to 36 months (high-risk patients) at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and then yearly 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 brachytherapy, ADT and LHRH agonist therapy) | Experimental | Radiation: Internal Radiation Therapy, Drug: Bicalutamide, Drug: Leuprolide Acetate, Drug: Goserelin Acetate, Drug: Triptorelin Pamoate, Drug: Degarelix, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life AssessmentPatients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Documented pathologic confirmation of prostate adenocarcinoma
- Clinical T-classification T1-3
- PSA < 150 ng/mL
- Gleason score 6-10
- Clinically negative lymph nodes as established by abdomino-pelvic CT. CT only for clinical classification of T3 (with contrast if renal function is acceptable; a non-contrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection. Patients with lymph nodes equivocal or questionable by imaging are eligible if those nodes are <1 cm in short axis diameter. [56]
Key exclusion criteria (11 listed)
- Clinical T4 disease
- PSA >= 150 ng/mL
- AUA SI > 20
- History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for prostate cancer
- Previous chemotherapy for any malignancy, if given within three years of registration
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 |
|---|---|---|
| Internal Radiation TherapyAlso: Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation BrachytherapyUndergo high-dose-rate brachytherapy | Radiation | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
| BicalutamideAlso: CDXGiven PO | Drug | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
| Leuprolide AcetateAlso: A-43818Given IM or SC | Drug | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
| Goserelin AcetateAlso: ICI-118630, ZDX, ZoladexGiven SC | Drug | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
| Triptorelin PamoateAlso: Pamorelin, TrelstarGiven IM | Drug | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
| DegarelixAlso: FE200486, FirmagonGiven SC | Drug | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
Primary outcome
Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0
Time frame: Within 6 months of HDR completion
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
10 secondary outcomes
Proportion of men with a nPSA12 of < 2 ng/mL
Time frame: Up to 1 year after completion of HDR
FFBF (Biochemical failure define according to PSA nadir+2ng/mL and 3 consecutive rises definition according to American Society of Radiation Oncology
Time frame: From the completion of all treatment to the time of BF, assessed at 5 years
Change in Quality of Life as Measured by Expanded Prostate Cancer Index Composite (EPIC) Scores
Time frame: Baseline to up to 5 years
Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores
Time frame: Up to 5 years
Pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer (association between each risk factor and the risk of having a first BF)
Time frame: Baseline
Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v4.0
Time frame: Within 6 months of HDR completion
Late GU toxicity, scored according to CTCAE v3.0 and v4.0
Time frame: Up to 5 years
Acute GI toxicity scored according to CTCAE v3.0 and CTCAE v4.0
Time frame: Up to 6 months after completing HDR BT
Late GI toxicity, scored according to CTCAE v3.0 and CTCAE v4.0
Time frame: Up to 5 years
Dosimetric predictors of toxicity (Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes)
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 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. This study is not recruiting at the moment.
Mark Buyyounouski principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Radiation Therapy, Bicalutamide and Leuprolide Acetate in people with Prostate Adenocarcinoma and Stage I Prostate Cancer, run by Stanford University 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 2 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0 (time frame: Within 6 months of HDR completion). 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 2 Jul 2026.