Prostate CancerPhase 3NCT01492972
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
A Phase 3 study testing Radiation and Androgen Suppression Therapy in people with Prostate Cancer, run by Proton Collaborative Group at 4 sites in United States.
Trial summary
The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. 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?
- Radiation and Androgen Suppression Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2012to 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 of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c
- Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended.
- PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
- ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
- Patients must sign IRB approved study specific informed consent.
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- Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
- Patients must be able to start treatment within 56 days of randomization.
- Patients must be at least 18 years old.
- For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
- For brachytherapy, prostate volume must be less than 55cc prior to AS.
Who cannot join
- Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
- Previous pelvic radiation for prostate cancer.
- Previous androgen suppression therapy for prostate cancer.
- Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
- Prior systemic chemotherapy for prostate cancer.
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- History of proximal urethral stricture requiring dilatation.
- 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 or to have a biopsy if needed).
- Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for 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).
- History of myocardial infarction within the last 6 months.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Hampton University Proton Therapy Institute
Hampton, Virginia, 23666
Donna Sternberg, RN, BSN, OCN, 757-251-6839, donna.Sternberg@hamptonproton.org
Christopher Sinesi, MD
- Recruiting
Oklahoma Proton Center
Oklahoma City, Oklahoma, 73142
Angela Beebe, 405-773-6708, angela.beebe@okcproton.com
John Chang, MD
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259-5499
: Clinical Trials Office - All Mayo Clinic Locations, 855-776-0015 (toll free)
- Recruiting
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, 60555
Don Smith, MS, CCRC, 630-933-7820, donald.smith3@nm.org
Arpi Thukral, MD
About this study
Official title: Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate
The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer.
Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.
- Conditions
- Prostate Cancer
- Being tested
- Radiation, Androgen Suppression Therapy
- Keywords
- Prostate, proton, radiation, intermediate risk
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Consists of:
- Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE))
- High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy)
- Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)
Androgen Suppression TherapyDrug
Also called leuprolide, goserelin, buserelin, or triptorelin
Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)
| Study group | Role | What they receive |
|---|---|---|
| Radiation Alone | Active comparator | Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy Receives: Radiation: Radiation |
| Radiation + Androgen Suppression | Experimental | Androgen Suppression Therapy x 6 months + Radiation Receives: Radiation: Radiation; Drug: Androgen Suppression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity Outcomes
To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression.
Freedom from failure (FFF): 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) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression
Measured: after the initial 100 patients have had a median follow up of at least three years and then every year.
Secondary outcomes (13)
Frequency and severity of grade 2 or higher GU and GI toxicity
Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria
Measured: At 6 months
Frequency and severity of GI and GU toxicity
Measured: At 3 years
Incidence of quality of life issues
Measured: At completion of radiation therapy
Incidence of Freedom from biochemical failure (FFBF)
Measured: At 5 years
Incidence of clinical failure: local and/or distant
Measured: At 5 years
Incidence of salvage Androgen Suppression use (SAD)
Measured: At 5 years
Incidence of progression free survival: using clinical, biochemical and SAD as events
Measured: At 5 years
Incidence of overall survival
Measured: At 5 years
Incidence of disease-specific survival
Measured: At 5 years
Correlate pathologic and radiologic findings with outcomes
Measured: At 5 years
Correlate PSA and free PSA levels with outcomes
Measured: At 5 years
Correlate testosterone levels and variation with proton therapy and outcomes
Measured: At 5 years
Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity
Measured: At 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proton Collaborative Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Carlos Vargas, MD, Principal investigator, Proton Collaborative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492972
- Sponsor's protocol ID
- GU003-10
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2011
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
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
- Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT01492972
- Acronym / sponsor ID
- GU003-10
- Conditions
- Prostate Cancer
- Keywords
- Prostate, proton, radiation, intermediate risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Proton Collaborative GroupResearch network
- Study start
- Jan 2012
- Primary completion
- Dec 2027 (estimated)
- First posted
- 15 Dec 2011 (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/or bad of two treatment methods on subjects and their cancer.
Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation Alone | Active comparator | Radiation: RadiationProton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy |
| Radiation + Androgen Suppression | Experimental | Radiation: Radiation, Drug: Androgen Suppression TherapyAndrogen Suppression Therapy x 6 months + Radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c
- Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended.
- PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
- ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
Key exclusion criteria (11 listed)
- Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
- Previous pelvic radiation for prostate cancer.
- Previous androgen suppression therapy for prostate cancer.
- Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
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 |
|---|---|---|
| RadiationConsists of: 1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE)) 2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy) 3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy) | Radiation | Radiation + Androgen Suppression, Radiation Alone |
| Androgen Suppression TherapyAlso: leuprolide, goserelin, buserelin, or triptorelinAndrogen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions) | Drug | Radiation + Androgen Suppression |
Primary outcome
Morbidity Outcomes
Time frame: after the initial 100 patients have had a median follow up of at least three years and then every year.
To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression. Freedom from failure (FFF): 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) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression
13 secondary outcomes
Frequency and severity of grade 2 or higher GU and GI toxicity
Time frame: At 6 months
Frequency and severity of GI and GU toxicity
Time frame: At 3 years
Incidence of quality of life issues
Time frame: At completion of radiation therapy
Incidence of Freedom from biochemical failure (FFBF)
Time frame: At 5 years
Incidence of clinical failure: local and/or distant
Time frame: At 5 years
Incidence of salvage Androgen Suppression use (SAD)
Time frame: At 5 years
Incidence of progression free survival: using clinical, biochemical and SAD as events
Time frame: At 5 years
Incidence of overall survival
Time frame: At 5 years
Incidence of disease-specific survival
Time frame: At 5 years
Correlate pathologic and radiologic findings with outcomes
Time frame: At 5 years
Correlate PSA and free PSA levels with outcomes
Time frame: At 5 years
Correlate testosterone levels and variation with proton therapy and outcomes
Time frame: At 5 years
Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity
Time frame: At 3 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 29 Sep 2026.
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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.
Northwestern Medicine Chicago Proton Center
Warrenville, United States
Carlos Vargas, MD principal investigator
Proton Collaborative Group
4 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 Radiation and Androgen Suppression Therapy in people with Prostate Cancer, run by Proton Collaborative Group at 4 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 11 inclusion and 11 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: looking for participants now, 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 4 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity Outcomes (time frame: after the initial 100 patients have had a median follow up of at least three years and then every year.). 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 29 Sep 2026.