Prostate CancerPhase 3NCT00667888
A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation
A Phase 3 study testing Conventional Fractionated Intensity Modulated Radiotherapy and Hypofractionated Intensity Modulated Radiotherapy in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Conventional Fractionated Intensity Modulated Radiotherapy and Hypofractionated Intensity Modulated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2001to Oct 2021
- Phase
- Phase 3
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy proof of adenocarcinoma of the prostate.
- Bone scan (If PSA >10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
- CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
- Suitable medical condition; Zubrod <2.
- Pretreatment PSA </=20 ng/ml. If PSA <4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification.
- Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system).
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- While a transrectal ultrasound will be obtained before treatment, the staging will not be based on these findings. If palpable T3 disease is present, then must have Gleason score <8 and pretreatment PSA less than or equal to 10 ng/ml
- Gleason score <10.
- If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml.
- The patient must be able to understand the protocol and adhere to follow-up at 6-month intervals for the first 2 years and at yearly intervals thereafter.
- Informed consent must be given.
- Patients randomized to Arm 1 may also participate in protocol 2004-0428.
Who cannot join
- Prior pelvic radiotherapy.
- Greater than 4 months of prior hormone ablation therapy.
- Prior or planned radical prostate surgery.
- Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.
- Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible.
- Zubrod status greater than or equal to 2.
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- Pretreatment PSA >20 ng/ml.
- Gleason score of 10.
- Palpable stage T3c (seminal vesicle involvement) or T4 disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. The safety of these treatments will also be studied and compared.
Read the detailed description
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group.
Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become the standard treatment at M.D. Anderson Cancer Center.
Patients in Group 2 will also be treated with IMRT. However, these patients will only receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients is higher than for Group 1 and has the possibility of killing more tumor cells.
Each external beam treatment requires about 10-20 minutes. However, patients can expect to spend 20 - 30 minutes on the treatment table because imaging measurements of prostate position will be done before each treatment. The total time in the radiation department each treatment day will be about an hour.
After the radiotherapy is completed, patients will have a PSA blood test every 3 months for 2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6 months during the first 2 years beginning 3 months after the completion of treatment, then annually. A needle biopsy of the prostate will be performed if these tests suggest recurrence.
This is an investigational study. 225 patients will take part in this study. This study will take place at M. D. Anderson and possibly some affiliated hospitals.
- Conditions
- Prostate Cancer
- Being tested
- Conventional Fractionated Intensity Modulated Radiotherapy, Hypofractionated Intensity Modulated Radiotherapy
- Keywords
- Prostate Cancer, Radiation, Radiotherapy, Intensity Modulated Radiotherapy, IMRT, Hypofractionated Intensity Modulated Radiotherapy, HIMRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Fractionated Intensity Modulated RadiotherapyRadiation
Also called IMRT
A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
Hypofractionated Intensity Modulated RadiotherapyRadiation
Also called HIMRT
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
| Study group | Role | What they receive |
|---|---|---|
| Intensity Modulated Radiotherapy (IMRT) | Active comparator | A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV). Receives: Radiation: Conventional Fractionated Intensity Modulated Radiotherapy |
| Hypofractionated Intensity Modulated Radiotherapy (HIMRT) | Experimental | A total dose of 72 Gy will be delivered in 30 fractions to the PTV. Receives: Radiation: Hypofractionated Intensity Modulated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)
To determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy.
Measured: 8.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study start3 Jan 2001
- Primary completion12 Oct 2015
- Study completionOct 2021 (estimated)
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.
- Publications (2)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 M.D. Anderson 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah A. Kuban, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667888
- Sponsor's protocol ID
- ID00-381
- Other IDs
- NCI-2010-01456
- Status last verified
- Jan 2021
- First submitted
- 24 Apr 2008
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hassanzadeh C, Kuban D, Pasyar S, Bassett R, Troncoso P, Ansari M, Schlembach P, McGuire S, Nguyen Q, Frank S, Mok H, Mohamad O, Park R, Tang C, Du W, Kudchadker R, Choi S, Hoffman K. Hypofractionated, Dose-Escalated Radiation Versus Conventionally Fractionated Radiation for Localized Prostate Cancer: Long-Term Update of a Phase III, Prospective, Randomized Controlled Trial. J Clin Oncol. 2025 Jun 20;43(18):2044-2048. doi: 10.1200/JCO-24-02057. Epub 2025 May 14.
PubMed 40367400Kim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2.
PubMed 36884035
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation
- ClinicalTrials.gov ID
- NCT00667888
- Acronym / sponsor ID
- ID00-381
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Radiation, Radiotherapy, Intensity Modulated Radiotherapy, IMRT, Hypofractionated Intensity Modulated Radiotherapy, HIMRT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 3 Jan 2001 (actual)
- Primary completion
- 12 Oct 2015 (actual)
- Study completion
- Oct 2021 (estimated)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 25 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. The safety of these treatments will also be studied and compared.
Detailed description
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group.
Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become the standard treatment at M.D. Anderson Cancer Center.
Patients in Group 2 will also be treated with IMRT. However, these patients will only receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients is higher than for Group 1 and has the possibility of killing more tumor cells.
Each external beam treatment requires about 10-20 minutes. However, patients can expect to spend 20 - 30 minutes on the treatment table because imaging measurements of prostate position will be done before each treatment. The total time in the radiation department each treatment day will be about an hour.
After the radiotherapy is completed, patients will have a PSA blood test every 3 months for 2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6 months during the first 2 years beginning 3 months after the completion of treatment, then annually. A needle biopsy of the prostate will be performed if these tests suggest recurrence.
This is an investigational study. 225 patients will take part in this study. This study will take place at M. D. Anderson and possibly some affiliated hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensity Modulated Radiotherapy (IMRT) | Active comparator | Radiation: Conventional Fractionated Intensity Modulated RadiotherapyA total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV). |
| Hypofractionated Intensity Modulated Radiotherapy (HIMRT) | Experimental | Radiation: Hypofractionated Intensity Modulated RadiotherapyA total dose of 72 Gy will be delivered in 30 fractions to the PTV. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Biopsy proof of adenocarcinoma of the prostate.
- Bone scan (If PSA >10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
- CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
- Suitable medical condition; Zubrod <2.
- Pretreatment PSA </=20 ng/ml. If PSA <4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification.
Key exclusion criteria (9 listed)
- Prior pelvic radiotherapy.
- Greater than 4 months of prior hormone ablation therapy.
- Prior or planned radical prostate surgery.
- Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.
- Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible.
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 |
|---|---|---|
| Conventional Fractionated Intensity Modulated RadiotherapyAlso: IMRTA total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV). | Radiation | Intensity Modulated Radiotherapy (IMRT) |
| Hypofractionated Intensity Modulated RadiotherapyAlso: HIMRTA total dose of 72 Gy will be delivered in 30 fractions to the PTV. | Radiation | Hypofractionated Intensity Modulated Radiotherapy (HIMRT) |
Primary outcome
Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)
Time frame: 8.5 years
To determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40367400Hassanzadeh C, Kuban D, Pasyar S, Bassett R, Troncoso P, Ansari M, Schlembach P, McGuire S, Nguyen Q, Frank S, Mok H, Mohamad O, Park R, Tang C, Du W, Kudchadker R, Choi S, Hoffman K. Hypofractionated, Dose-Escalated Radiation Versus Conventionally Fractionated Radiation for Localized Prostate Cancer: Long-Term Update of a Phase III, Prospective, Randomized Controlled Trial. J Clin Oncol. 2025 Jun 20;43(18):2044-2048. doi: 10.1200/JCO-24-02057. Epub 2025 May 14.
- Derived from this study: PubMed 36884035Kim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2.
- MD Anderson 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.
Deborah A. Kuban, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional Fractionated Intensity Modulated Radiotherapy and Hypofractionated Intensity Modulated Radiotherapy in people with Prostate Cancer, run by M.D. Anderson 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 12 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: status not confirmed, as of the sponsor's last update on 25 Jan 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Jan 2021). 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?
Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT) (time frame: 8.5 years). 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 NCT00667888, which also lists 2 linked publications.
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 25 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.