Prostate CancerPhase 1NCT00911118
Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
A Phase 1 study testing Hypofractionated, image-guided, intensity-modulated external beam radiation in people with Prostate Cancer and Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to test the safety of a new type of IG-IMRT called "ultra-hypofractionated IG-IMRT" where a higher dose of radiation is given to the tumor during each treatment day. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma
- What is being tested?
- Hypofractionated, image-guided, intensity-modulated external beam radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 May 2009to 14 May 2026
- Phase
- Phase 1
- 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 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient.
- Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.
- Low risk patients will be defined as:
- PSA < or = to 10 ng/ml and
- Gleason score = 6 and
- Clinical Stage < or = to T2a
Show all 16Show fewer
- Intermediate risk patients will be defined as:
- PSA 10-20 ng/ml or
- Gleason score = 7 or
- Clinical stage T2b/T2c
- Additionally, patients will be required to meet the following criteria:
- Age > or = to 18
- KPS > or = to 70
- Pre-treatment endorectal coil MRI or CT (MRI preferred) at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease
- Prostate size < or = to 60 cc
- International Prostate Symptom Score < or = to 15
Who cannot join
- Prior androgen deprivation therapy for prostate cancer
- Elective pelvic lymph node irradiation
- KPS < 70
- Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease
- Presence of distant metastasis as determined by:
- o alkaline phosphatase > or = to ULN or
Show all 18Show fewer
- whole body bone scan positive for osseous metastases
- Prior history of transurethral resection of the prostate
- Prior history of chronic prostatitis
- Prior history of urethral stricture
- Prior history of pelvic irradiation
- History of inflammatory bowel disease
- Unable to give informed consent
- Unable to complete quality of life questionnaires Abnormal complete blood count. Any of the following
- Platelet count less than 75,000/ml
- Hb level less than 10 gm/dl
- WBC less than 3.5/ml
- Abnormal renal function tests (creatinine > 1.5)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
Memorial Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York
Montefiore Medical Center
The Bronx, New York, 10467
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Phase I Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
The purpose of this study is to test the safety of a new type of IG-IMRT called "ultra-hypofractionated IG-IMRT" where a higher dose of radiation is given to the tumor during each treatment day. Since higher doses of radiation are used each day, the total number of treatment days needed to complete this type of radiation is only five instead of the 45-48 treatments currently used. Treatment takes place every other day and is complete after 2 weeks. If the patient decides to get this treatment, they will come in for 5 treatments. This is different from the 48 treatments they would get normally.
- Conditions
- Prostate Cancer, Adenocarcinoma
- Being tested
- Hypofractionated, image-guided, intensity-modulated external beam radiation
- Keywords
- prostate, radiation, 09-035
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated, image-guided, intensity-modulated external beam radiationRadiation
A standard dose escalation design is utilized, with the initial treatment assigned as 6.5 Gy/fraction for five fractions to a total dose of 32.5 Gy. For any given dose tier, an initial cohort of 30 patients will be treated. However to adjust for potentially inevaluable patients who dropout prior to a full toxicity collection to assess potential DLTs enrollment of up to five additional patients per cohort can occur, per PI's discretion. Dose escalation will proceed if < 10% of the 30 patients treated per tier exhibit any dose limiting toxicity (DLT) once the entire tier cohort has a minimum follow-up of 3 months and half the tier cohort has a minimum follow-up of 6 months. Dose escalation to the next tier will occur by increasing the dose per fraction by 0.5 Gy while keeping the fraction number constant at 5, leading to a total dose increase of 2.5 Gy per dose tier.
| Study group | Role | What they receive |
|---|---|---|
| Radiation | Experimental | Patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced as MSKCC. MSKCC patients will have the option of continued follow-up through MSKCC's established Prostate Survivorship Clinic for an indefinite period of time, meaning patients enrolled in the protocol will be encouraged to remain at MSKCC for life-long follow-up after their treatment. The standard assessments obtained in the Survivorship Clinic will not be altered. All protocol relevant data collected at these visits through month 60 will be used for protocol analysis. Receives: Radiation: Hypofractionated, image-guided, intensity-modulated external beam radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer.
Measured: With at least one status check visit during the course of treatment.
Secondary outcomes (3)
Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival.
Measured: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
Evaluate pathologic response rates at 24-36 months via repeat biopsy.
Measured: 24-36 months post treatment
Evaluate the effect of treatment on sexual function.
Measured: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study start26 May 2009
- Primary completion14 May 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Sean McBride, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911118
- Sponsor's protocol ID
- 09-035
- Status last verified
- May 2026
- First submitted
- 28 May 2009
- Last updated
- 18 May 2026
- Results posted
- No
Publications
Moore A, Kollmeier MA, McBride SM, Toumbacaris N, Zhang Z, Lacy-Elsayegh A, Dreyfuss A, Grossman CE, Gorovets D, Zelefsky MJ. Long-term Outcomes from a Phase 1 Dose Escalation Study Using Stereotactic Body Radiotherapy for Patients with Low- or Intermediate-risk Prostate Cancer. Eur Urol Oncol. 2024 Aug;7(4):812-820. doi: 10.1016/j.euo.2023.10.019. Epub 2023 Nov 10.
PubMed 37949730
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
- ClinicalTrials.gov ID
- NCT00911118
- Acronym / sponsor ID
- 09-035
- Conditions
- Prostate Cancer, Adenocarcinoma
- Keywords
- prostate, radiation, 09-035
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Montefiore Medical Center
- Study start
- 26 May 2009 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 1 Jun 2009 (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.
The purpose of this study is to test the safety of a new type of IG-IMRT called "ultra-hypofractionated IG-IMRT" where a higher dose of radiation is given to the tumor during each treatment day. Since higher doses of radiation are used each day, the total number of treatment days needed to complete this type of radiation is only five instead of the 45-48 treatments currently used. Treatment takes place every other day and is complete after 2 weeks. If the patient decides to get this treatment, they will come in for 5 treatments. This is different from the 48 treatments they would get normally.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation | Experimental | Radiation: Hypofractionated, image-guided, intensity-modulated external beam radiationPatients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced as MSKCC. MSKCC patients will have the option of continued follow-up through MSKCC's established Prostate Survivorship Clinic for an indefinite period of time, meaning patients enrolled in the protocol will be encouraged to remain at MSKCC for life-long follow-up after their treatment. The standard assessments obtained in the Survivorship Clinic will not be altered. All protocol relevant data collected at these visits through month 60 will be used for protocol analysis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient.
- Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.
- Low risk patients will be defined as:
- Intermediate risk patients will be defined as:
- Age > or = to 18
Key exclusion criteria (18 listed)
- Prior androgen deprivation therapy for prostate cancer
- o alkaline phosphatase > or = to ULN or
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 |
|---|---|---|
| Hypofractionated, image-guided, intensity-modulated external beam radiationA standard dose escalation design is utilized, with the initial treatment assigned as 6.5 Gy/fraction for five fractions to a total dose of 32.5 Gy. For any given dose tier, an initial cohort of 30 patients will be treated. However to adjust for potentially inevaluable patients who dropout prior to a full toxicity collection to assess potential DLTs enrollment of up to five additional patients per cohort can occur, per PI's discretion. Dose escalation will proceed if < 10% of the 30 patients treated per tier exhibit any dose limiting toxicity (DLT) once the entire tier cohort has a minimum follow-up of 3 months and half the tier cohort has a minimum follow-up of 6 months. Dose escalation to the next tier will occur by increasing the dose per fraction by 0.5 Gy while keeping the fraction number constant at 5, leading to a total dose increase of 2.5 Gy per dose tier. | Radiation | Radiation |
Primary outcome
Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer.
Time frame: With at least one status check visit during the course of treatment.
3 secondary outcomes
Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival.
Time frame: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
Evaluate pathologic response rates at 24-36 months via repeat biopsy.
Time frame: 24-36 months post treatment
Evaluate the effect of treatment on sexual function.
Time frame: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
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 18 May 2026.
- Derived from this study: PubMed 37949730Moore A, Kollmeier MA, McBride SM, Toumbacaris N, Zhang Z, Lacy-Elsayegh A, Dreyfuss A, Grossman CE, Gorovets D, Zelefsky MJ. Long-term Outcomes from a Phase 1 Dose Escalation Study Using Stereotactic Body Radiotherapy for Patients with Low- or Intermediate-risk Prostate Cancer. Eur Urol Oncol. 2024 Aug;7(4):812-820. doi: 10.1016/j.euo.2023.10.019. Epub 2023 Nov 10.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Sean McBride, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hypofractionated, image-guided, intensity-modulated external beam radiation in people with Prostate Cancer and Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 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 16 inclusion and 18 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 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer. (time frame: With at least one status check visit during the course of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911118, which also lists 1 linked publication.
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 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.