Prostate CancerPhase 3NCT01230866
Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer
A Phase 3 study testing Proton Radiation Hypofractionation and Proton Radiation Standard Fractionation in people with Prostate Cancer, run by Proton Collaborative Group at 5 sites in United States.
Trial summary
The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Proton Radiation Hypofractionation and Proton Radiation Standard Fractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2010to Dec 2027
- Phase
- Phase 3
- 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 prostate adenocarcinoma within 365 days prior to randomization.
- History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly recommended.
- PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.
- Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.
- No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
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- Patients must be at least 18 years old.
- ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.
- IPSS score <= 16.
- Patients must give IRB approved, study specific, informed consent.
- Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.
- Patients must be able to start treatment within 56 days of randomization.
Who cannot join
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
- Previous pelvic radiation for prostate cancer.
- Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.
- Prior systemic chemotherapy for prostate cancer.
- History of proximal urethral stricture requiring dilatation.
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- Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).
- Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study.
- Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Hampton University Proton Therapy Institute
Hampton, Virginia, 23666
Oklahoma Proton Center
Oklahoma City, Oklahoma, 73142
Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, 60555
About this study
Official title: A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate
The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.
- Conditions
- Prostate Cancer
- Being tested
- Proton Radiation Hypofractionation, Proton Radiation Standard Fractionation
- Keywords
- Proton Radiation 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.
Proton Radiation HypofractionationRadiation
Also called Particle Therapy
Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks
Proton Radiation Standard FractionationRadiation
Also called Particle Therapy
Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Proton Radiation Hypofractionation | Other | 5 fractions (7.6 Gy(RBE) x 5) Receives: Radiation: Proton Radiation Hypofractionation |
| Proton Radiation Standard Fractionation | Active comparator | 44 fractions (1.8 Gy(RBE) x 44) Receives: Radiation: Proton Radiation Standard Fractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA),or the start of salvage therapy including androgen deprivation.
Measured: At 5 years post treatment completion +/- 90 days
Secondary outcomes (1)
To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.
Measured: At 6 months and 2 years post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2027 (estimated)
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.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proton Collaborative Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Carlos Vargas, MD, Study chair, Proton Collaborative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230866
- Sponsor's protocol ID
- GU002-10
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2010
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Toesca DAS, Hartsell WF, DeWees TA, Chang JH, Laughlin BS, Voss MM, Dodoo CA, Mohammed N, Keole SR, McGee LA, Gondi V, Sweeney PJ, Dorn P, Sinesi CC, Doh LS, Rich T, Vargas CE. Stereotactic Body Proton Therapy Versus Conventionally Fractionated Proton Therapy for Early Prostate Cancer: A Randomized, Controlled, Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2024 Dec 1;120(5):1377-1385. doi: 10.1016/j.ijrobp.2024.05.014. Epub 2024 Jul 6.
PubMed 38972465
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT01230866
- Acronym / sponsor ID
- GU002-10
- Conditions
- Prostate Cancer
- Keywords
- Proton Radiation Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Proton Collaborative GroupResearch network
- Study start
- Nov 2010
- Primary completion
- Dec 2027 (estimated)
- First posted
- 29 Oct 2010 (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 compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton Radiation Hypofractionation | Other | Radiation: Proton Radiation Hypofractionation5 fractions (7.6 Gy(RBE) x 5) |
| Proton Radiation Standard Fractionation | Active comparator | Radiation: Proton Radiation Standard Fractionation44 fractions (1.8 Gy(RBE) x 44) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.
- History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly recommended.
- PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.
- Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.
Key exclusion criteria (9 listed)
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
- Previous pelvic radiation for prostate cancer.
- Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.
- Prior systemic chemotherapy for prostate cancer.
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 |
|---|---|---|
| Proton Radiation HypofractionationAlso: Particle TherapyDose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks | Radiation | Proton Radiation Hypofractionation |
| Proton Radiation Standard FractionationAlso: Particle TherapyDose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks | Radiation | Proton Radiation Standard Fractionation |
Primary outcome
To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
Time frame: At 5 years post treatment completion +/- 90 days
The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA),or the start of salvage therapy including androgen deprivation.
1 secondary outcome
To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.
Time frame: At 6 months and 2 years post randomization
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 29 Sep 2026.
- Derived from this study: PubMed 38972465Toesca DAS, Hartsell WF, DeWees TA, Chang JH, Laughlin BS, Voss MM, Dodoo CA, Mohammed N, Keole SR, McGee LA, Gondi V, Sweeney PJ, Dorn P, Sinesi CC, Doh LS, Rich T, Vargas CE. Stereotactic Body Proton Therapy Versus Conventionally Fractionated Proton Therapy for Early Prostate Cancer: A Randomized, Controlled, Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2024 Dec 1;120(5):1377-1385. doi: 10.1016/j.ijrobp.2024.05.014. Epub 2024 Jul 6.
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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.
Carlos Vargas, MD study chair
Proton Collaborative Group
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Proton Radiation Hypofractionation and Proton Radiation Standard Fractionation in people with Prostate Cancer, run by Proton Collaborative Group at 5 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 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
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?
To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy. (time frame: At 5 years post treatment completion +/- 90 days). 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 NCT01230866, 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 29 Sep 2026.