Adenocarcinoma of the ProstatePhase 1/2NCT01517451
Radiation and Androgen Ablation for Prostate Cancer
A Phase 1/2 study testing Radiation Therapy and Androgen Deprivation Therapy (ADT) in people with Adenocarcinoma of the Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.
Trial summary
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Radiation Therapy and Androgen Deprivation Therapy (ADT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 May 2013to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, locally confined adenocarcinoma of the prostate
- Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).
- The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.
- Signed study-specific consent form prior to registration
Who cannot join
- Stage T3-4 disease.
- Gleason 8 or higher score.
- PSA > 20 ng/ml.
- IPSS (International Prostate Symptom Score) > 15
- Clinical or Pathological Lymph node involvement (N1).
- Evidence of distant metastases (M1).
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- Radical surgery for carcinoma of the prostate.
- Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer.
- Previous pelvic radiation therapy.
- Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years.
- History of inflammatory bowel disease.
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
- Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11
- Liver function tests (LFTs) greater than twice the upper limit of normal.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Suburban Hospital
Bethesda, Maryland, 20814
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.
Read the detailed description
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Radiation Therapy, Androgen Deprivation Therapy (ADT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Androgen Deprivation Therapy (ADT)Drug
Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
| Study group | Role | What they receive |
|---|---|---|
| Radiation with Androgen Deprivation Therapy (ADT) | Experimental | This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. Receives: Radiation: Radiation Therapy; Drug: Androgen Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).
To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events.
Measured: From consent up to 5 years post treatment completion
Secondary outcomes (6)
Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events
Incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.
Measured: Consent to up to 5 years of follow-up or biochemical failure.
Overall Survival Rate
Assess clinical control rate by measuring the Overall Survival (OS) which is defined as the percentage of participants who completed the study that lived from time of treatment until death from any cause.
Measured: Start of treatment up to 5 years
Number of Patients Who Completed Blood Collection of Whole Blood for Future Research
Biomarker studies. Number of patients who completed blood collection of whole blood for future research.
Measured: Up to 2 years post treatment
Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).
The International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for Benign prostatic hyperplasia (BPH) patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of Lower Urinary Tract Symptoms (LUTS) and quality of life. Patients can fill out the IPSS form before examinations, but minimal interference from health care providers must be ensured. Total score range 0-35; A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic.
Measured: Measured at baseline and at 3, 12, 24 and 36 months post treatment
Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment
The SHIM serves several key functions within clinical and research settings. Its core purpose involves screening for and evaluating the severity of erectile dysfunction (ED). Total score range 5 to 25; higher scores indicate better erectile function. A total score of 21 or less indicates erectile dysfunction. 22-25: No erectile dysfunction, 17-21: Mild ED, 12-16: Mild-to-moderate ED, 8-11: Moderate ED, 5-7: Severe ED.
Measured: Baseline and at 3,12, 24 and 36 months follow-up
The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health
The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring sexual health related quality of life. Scores range from 1 to 100, with higher scores being better score.
Measured: 3,12, 24 and 36 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study start22 May 2013
- Primary completion28 Feb 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Song, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517451
- Sponsor's protocol ID
- J11157
- Other IDs
- NA_00067963
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2012
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT01517451
- Acronym / sponsor ID
- J11157
- Conditions
- Adenocarcinoma of the Prostate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 22 May 2013 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Posted 11 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.
Detailed description
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation with Androgen Deprivation Therapy (ADT) | Experimental | Radiation: Radiation Therapy, Drug: Androgen Deprivation Therapy (ADT)This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed, locally confined adenocarcinoma of the prostate
- Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).
- The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.
- Signed study-specific consent form prior to registration
Key exclusion criteria (14 listed)
- Stage T3-4 disease.
- Gleason 8 or higher score.
- PSA > 20 ng/ml.
- IPSS (International Prostate Symptom Score) > 15
- Clinical or Pathological Lymph node involvement (N1).
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 |
|---|---|---|
| Radiation Therapy7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) | Radiation | Radiation with Androgen Deprivation Therapy (ADT) |
| Androgen Deprivation Therapy (ADT)Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT. | Drug | Radiation with Androgen Deprivation Therapy (ADT) |
Primary outcome
Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).
Time frame: From consent up to 5 years post treatment completion
To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events.
6 secondary outcomes
Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events
Time frame: Consent to up to 5 years of follow-up or biochemical failure.
Overall Survival Rate
Time frame: Start of treatment up to 5 years
Number of Patients Who Completed Blood Collection of Whole Blood for Future Research
Time frame: Up to 2 years post treatment
Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).
Time frame: Measured at baseline and at 3, 12, 24 and 36 months post treatment
Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment
Time frame: Baseline and at 3,12, 24 and 36 months follow-up
The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health
Time frame: 3,12, 24 and 36 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel Song, M.D. principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiation Therapy and Androgen Deprivation Therapy (ADT) in people with Adenocarcinoma of the Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites 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 4 inclusion and 14 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT). (time frame: From consent up to 5 years post treatment 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 11 Feb 2026.