Stage I Prostate Adenocarcinoma AJCC v7Phase 2NCT01950351
Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
A Phase 2 study testing Laboratory Biomarker Analysis, Proton Beam Radiation Therapy and Quality-of-Life Assessment in people with Stage I Prostate Adenocarcinoma AJCC v7 and Stage II Prostate Adenocarcinoma AJCC v7, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage I Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7
- What is being tested?
- Laboratory Biomarker Analysis, Proton Beam Radiation Therapy and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2013to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year of study entry; evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson
- History/physical examination with digital rectal examination of the prostate within 90 days prior to registration
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material demonstrating Gleason score 2-7 within 365 days of registration
- Clinical stage T1-2b (American Joint Committee on Cancer [AJCC] 7th edition) and PSA < 20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
- Zubrod performance status 0-1 within 90 days prior to registration
- Patient must be able to provide study-specific informed consent prior to study entry
- Willingness and ability to complete the EPIC questionnaire
Who cannot join
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 years
- Evidence of distant metastases
- Regional lymph node involvement
- Previous prostatectomy, cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
- Previous pelvic radiation or prostate brachytherapy
- Active and severe medical co-morbidity defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration, hepatic insufficiency resulting in clinical jaundice, active inflammatory bowel disease (Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or congenital coagulation defects (patients on medical therapy with Coumadin or other blood thinning agents are eligible for participation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma
This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
Read the detailed description
PRIMARY OBJECTIVES:
- Estimate the incidence of grade 2 gastrointestinal toxicity following the proposed treatment regimens at 2 years post-treatment.
SECONDARY OBJECTIVES:
- Estimate the change in health related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment as defined by Expanded Prostate Cancer Index Composite (EPIC), Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire.
II. Estimate the rates of acute toxicity of the treatment regimens. III. Estimate the rates of late toxicity at 3, 4, and 5 years post-treatment. IV. Assess the efficacy of hypo-fractionated proton beam therapy, defined by the incidence of a rising prostate-specific antigen (PSA) at 5 years.
- Determine the rate of local failure by biopsy of the prostate when objective tests, prostate-specific antigen (PSA), magnetic resonance imaging (MRI), digital rectal exam (DRE), suggest relapse.
OUTLINE:
Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.
After completion of study treatment, patients are followed up every 6-12 months for 24 months and then annually until month 60.
- Being tested
- Laboratory Biomarker Analysis, Proton Beam Radiation Therapy, Quality-of-Life Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Proton Beam Radiation TherapyRadiation
Also called PBRT, Proton Radiation Therapy
Undergo proton beam radiation therapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (proton beam radiation therapy) | Experimental | Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks. Receives: Other: Laboratory Biomarker Analysis; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity
The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.
Measured: Up to 2 years post-treatment
Secondary outcomes (5)
Rates of acute toxicity
Rates of acute toxicity will be assessed.
Measured: Within 90 days of treatment initiation
Rate of late toxicity
Rate of late toxicity will be determined.
Measured: Up to 5 years post-treatment
Change in health related quality of life (HRQOL) as assessed by the Expanded Prostate Cancer Index Composite (EPIC) Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire
Change in HRQOL will be evaluated.
Measured: Baseline to up to 5 years
Incidence of rising prostate-specific antigen (PSA)
Incidence of rising PSA will be assessed.
Measured: At 5 years
Rate of local failure by biopsy
Rate of local failure by biopsy will be evaluated.
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 posted25 Sep 2013 (estimated)
- Study start10 Oct 2013
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Prostate Adenocarcinoma AJCC v7Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven J Frank, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950351
- Sponsor's protocol ID
- 2012-1003
- Other IDs
- NCI-2013-02347, 2012-1003
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2013
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01950351
- Acronym / sponsor ID
- 2012-1003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 241 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 25 Sep 2013 (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 phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
Detailed description
PRIMARY OBJECTIVES:
- Estimate the incidence of grade 2 gastrointestinal toxicity following the proposed treatment regimens at 2 years post-treatment.
SECONDARY OBJECTIVES:
- Estimate the change in health related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment as defined by Expanded Prostate Cancer Index Composite (EPIC), Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire.
II. Estimate the rates of acute toxicity of the treatment regimens. III. Estimate the rates of late toxicity at 3, 4, and 5 years post-treatment. IV. Assess the efficacy of hypo-fractionated proton beam therapy, defined by the incidence of a rising prostate-specific antigen (PSA) at 5 years.
- Determine the rate of local failure by biopsy of the prostate when objective tests, prostate-specific antigen (PSA), magnetic resonance imaging (MRI), digital rectal exam (DRE), suggest relapse.
OUTLINE:
Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.
After completion of study treatment, patients are followed up every 6-12 months for 24 months and then annually until month 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (proton beam radiation therapy) | Experimental | Other: Laboratory Biomarker Analysis, Radiation: Proton Beam Radiation Therapy, Other: Quality-of-Life AssessmentPatients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year of study entry; evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson
- History/physical examination with digital rectal examination of the prostate within 90 days prior to registration
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material demonstrating Gleason score 2-7 within 365 days of registration
- Clinical stage T1-2b (American Joint Committee on Cancer [AJCC] 7th edition) and PSA < 20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
- Zubrod performance status 0-1 within 90 days prior to registration
Key exclusion criteria (6 listed)
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 years
- Evidence of distant metastases
- Regional lymph node involvement
- Previous prostatectomy, cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
- Previous pelvic radiation or prostate brachytherapy
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (proton beam radiation therapy) |
| Proton Beam Radiation TherapyAlso: PBRT, Proton Radiation TherapyUndergo proton beam radiation therapy | Radiation | Treatment (proton beam radiation therapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (proton beam radiation therapy) |
Primary outcome
Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity
Time frame: Up to 2 years post-treatment
The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.
5 secondary outcomes
Rates of acute toxicity
Time frame: Within 90 days of treatment initiation
Rate of late toxicity
Time frame: Up to 5 years post-treatment
Change in health related quality of life (HRQOL) as assessed by the Expanded Prostate Cancer Index Composite (EPIC) Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire
Time frame: Baseline to up to 5 years
Incidence of rising prostate-specific antigen (PSA)
Time frame: At 5 years
Rate of local failure by biopsy
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Steven J Frank 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 2 study testing Laboratory Biomarker Analysis, Proton Beam Radiation Therapy and Quality-of-Life Assessment in people with Stage I Prostate Adenocarcinoma AJCC v7 and Stage II Prostate Adenocarcinoma AJCC v7, 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity (time frame: Up to 2 years post-treatment). 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 16 Jun 2026.