Prostate CancerPhase 2NCT00809991
Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate
A Phase 2 study testing hypofractionation in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This will be a Phase II study evaluating the effectiveness and toxicity of a specific radiation therapy regimen. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- hypofractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2008to Sep 2025
- Phase
- Phase 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
- Clinical stages T1a to T2b PSA of less than 10 ng per ml
- Gleason score of less than 3+4=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 to 4 disease
- Gleason 4+3=7 or higher score
- PSA greater than 10 ng per ml
- Clinical or Pathological Lymph node involvement N1
- Evidence of distant metastases M1
- Radical surgery for carcinoma of the prostate
Show all 10Show fewer
- Previous Chemotherapy or 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins University School of Medicne
Baltimore, Maryland, 21231
About this study
This will be a Phase II study evaluating the effectiveness and toxicity of a specific radiation therapy regimen. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. The total dose is calculated to be effective for late effects which has been shown to be effective and safe in a large prospective Phase II study. If the hypothesis for the prostate is is true, then this regimen should be at least as effective or more effective for tumor control than the current conventional therapy.
Read the detailed description
Radiation therapy is an effective and frequently utilized modality for the treatment of clinically localized prostate cancer. Traditionally, external beam radiation has been delivered in a fractionated manner using daily doses of 1.8-2.0 Gy. This daily dose was derived from early animal experiments and clinical experience, supported by mathematical models of normal tissue and tumor response to fraction size. The most widely used of these models is the linear-quadratic formula, which predicts responses to different fraction sizes based on the alpha/beta ratio of any given tissue.
One of the main motivations for delivering a treatment at low dose rate or with many fractions is that late-responding normal tissue are generally more sensitive than early-responding tissues (i.e. tumor) to increases in fraction size. So increasing the number of fractions generally spares late-responding tissues more than the tumor. This can be quantified in terms of the alpha/beta ratio:
- Small alpha/beta ratio (2-4 Gy), typical of late sequelae, means high sensitivity to fractionation changes.
- Large alpha/beta ratio (>8 Gy), typical of tumor control, means low sensitivity to fractionation changes.
It is generally assumed that the mechanistic basis for the different fractionation response of tumors and late-responding normal tissues relates to the larger proportion of cycling cells in tumors. But prostate tumors contain unusually small fractions of cycling cells. Brenner and Hall as well as Duchesne and Peters have reasoned that prostate tumors might not respond to changes in fractionation in the same way as other cancers; both papers hypothesize that prostate tumors might respond to changes in fractionation or dose rate more like a late-responding normal tissue. , In mathematical terms, the suggestion is that the alpha/beta ratio for prostate cancer might be low, comparable to that for late-responding tissues or even lower. Previous estimates of alpha/beta ratios of normal tissue and tumor tissue have generally been 3 and 10, respectively. Recent evidence has estimated the alpha/beta ratio of prostate cancer to be as low as 1.5. If these hypotheses are true, then the optimal therapeutic ratio for prostate cancer would be achieved using daily doses higher than 2 Gy.
Several preliminary clinical reports have found reasonable PSA control rates and no increase in late toxicity using doses of 2.5 to 3 Gy. Kupelian from the Mayo Clinic found PSA-free survival rates of 97%, 88%, and 70% in low-, intermediate-, and high-risk patients, respectively. The dose regimen used was 70 Gy in 2.5 Gy daily fractions. Both acute and late toxicity were not higher than seen with typical dose regimens. A group from Christie Hospital reported 82%, 56%, and 39% 5-year biochemical disease free survival rates (low, intermediate, and high risk, respectively) in patients treated with 50 Gy in 16 fractions (3.125 Gy per fraction), with acceptable bowel and bladder toxicity.
These results, although promising, require further validation. If the hypothesis that prostate cancer alpha/beta ratio is lower than normal tissue is correct, then the optimal fractional dose is likely to be even higher than the doses tested thus far, but if incorrect, the result may be increased normal tissue toxicity.
- Conditions
- Prostate Cancer
- Being tested
- hypofractionation
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionationRadiation
3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiation therapy in prostate adenocarcinoma | Experimental | Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). Receives: Radiation: hypofractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Assess the number of participants of grade 2 or greater GU and GI toxicity
Measured: Up to 5 years
Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS
The International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for BPH patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of 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: Baseline, 12 -, 24 -, and 36-month follow-up
The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
The SHIM serves several key functions within clinical and research settings. Its core purpose involves screening for and evaluating the severity of erectile dysfunction. 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, 12 months, 24 months, and 36-month follow-up
EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. Score range from 1 to 100, with higher scores better score.
Measured: Baseline, 12 months, 24 months, and 36-month follow-up
Secondary outcomes (1)
Number of Patients With Biochemical Failure Associated With the Hypofractionated Dose Regimen
Biochemical control rate (Failure Free Rate-BFFR) is defined as a binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years. Patients with biochemical failure are reported.
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 posted17 Dec 2008 (estimated)
- Study start22 Dec 2008
- Primary completion24 Jul 2024
- Study completionSep 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 Prostate CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danny Song, MD, Principal investigator, The Johns Hopkins University School of Medcine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809991
- Sponsor's protocol ID
- J0859
- Other IDs
- NA_00019393
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2008
- Last updated
- 18 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00809991
- Acronym / sponsor ID
- J0859
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 22 Dec 2008 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- Sep 2025 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 18 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a Phase II study evaluating the effectiveness and toxicity of a specific radiation therapy regimen. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. The total dose is calculated to be effective for late effects which has been shown to be effective and safe in a large prospective Phase II study. If the hypothesis for the prostate is is true, then this regimen should be at least as effective or more effective for tumor control than the current conventional therapy.
Detailed description
Radiation therapy is an effective and frequently utilized modality for the treatment of clinically localized prostate cancer. Traditionally, external beam radiation has been delivered in a fractionated manner using daily doses of 1.8-2.0 Gy. This daily dose was derived from early animal experiments and clinical experience, supported by mathematical models of normal tissue and tumor response to fraction size. The most widely used of these models is the linear-quadratic formula, which predicts responses to different fraction sizes based on the alpha/beta ratio of any given tissue.
One of the main motivations for delivering a treatment at low dose rate or with many fractions is that late-responding normal tissue are generally more sensitive than early-responding tissues (i.e. tumor) to increases in fraction size. So increasing the number of fractions generally spares late-responding tissues more than the tumor. This can be quantified in terms of the alpha/beta ratio:
- Small alpha/beta ratio (2-4 Gy), typical of late sequelae, means high sensitivity to fractionation changes.
- Large alpha/beta ratio (>8 Gy), typical of tumor control, means low sensitivity to fractionation changes.
It is generally assumed that the mechanistic basis for the different fractionation response of tumors and late-responding normal tissues relates to the larger proportion of cycling cells in tumors. But prostate tumors contain unusually small fractions of cycling cells. Brenner and Hall as well as Duchesne and Peters have reasoned that prostate tumors might not respond to changes in fractionation in the same way as other cancers; both papers hypothesize that prostate tumors might respond to changes in fractionation or dose rate more like a late-responding normal tissue. , In mathematical terms, the suggestion is that the alpha/beta ratio for prostate cancer might be low, comparable to that for late-responding tissues or even lower. Previous estimates of alpha/beta ratios of normal tissue and tumor tissue have generally been 3 and 10, respectively. Recent evidence has estimated the alpha/beta ratio of prostate cancer to be as low as 1.5. If these hypotheses are true, then the optimal therapeutic ratio for prostate cancer would be achieved using daily doses higher than 2 Gy.
Several preliminary clinical reports have found reasonable PSA control rates and no increase in late toxicity using doses of 2.5 to 3 Gy. Kupelian from the Mayo Clinic found PSA-free survival rates of 97%, 88%, and 70% in low-, intermediate-, and high-risk patients, respectively. The dose regimen used was 70 Gy in 2.5 Gy daily fractions. Both acute and late toxicity were not higher than seen with typical dose regimens. A group from Christie Hospital reported 82%, 56%, and 39% 5-year biochemical disease free survival rates (low, intermediate, and high risk, respectively) in patients treated with 50 Gy in 16 fractions (3.125 Gy per fraction), with acceptable bowel and bladder toxicity.
These results, although promising, require further validation. If the hypothesis that prostate cancer alpha/beta ratio is lower than normal tissue is correct, then the optimal fractional dose is likely to be even higher than the doses tested thus far, but if incorrect, the result may be increased normal tissue toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiation therapy in prostate adenocarcinoma | Experimental | Radiation: hypofractionationParticipants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed, locally confined adenocarcinoma of the prostate
- Clinical stages T1a to T2b PSA of less than 10 ng per ml
- Gleason score of less than 3+4=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 (10 listed)
- Stage T3 to 4 disease
- Gleason 4+3=7 or higher score
- PSA greater than 10 ng per ml
- Clinical or Pathological Lymph node involvement N1
- Evidence of distant metastases M1
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 |
|---|---|---|
| hypofractionation3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). | Radiation | Hypofractionated radiation therapy in prostate adenocarcinoma |
Primary outcome
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Time frame: Up to 5 years
Assess the number of participants of grade 2 or greater GU and GI toxicity
Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS
Time frame: Baseline, 12 -, 24 -, and 36-month follow-up
The International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for BPH patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of 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.
The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
Time frame: Baseline, 12 months, 24 months, and 36-month follow-up
The SHIM serves several key functions within clinical and research settings. Its core purpose involves screening for and evaluating the severity of erectile dysfunction. 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.
EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
Time frame: Baseline, 12 months, 24 months, and 36-month follow-up
The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. Score range from 1 to 100, with higher scores better score.
1 secondary outcome
Number of Patients With Biochemical Failure Associated With the Hypofractionated Dose Regimen
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
Danny Song, MD principal investigator
The Johns Hopkins University School of Medcine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hypofractionation in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 5 inclusion and 10 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 18 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 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.
What does this phase mean?
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 18 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?
Number of Participants With Grade 2 or Greater GU and GI Toxicity (time frame: Up to 5 years). The study lists 4 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 18 Feb 2026.