Prostate CancerNCT00969111
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
A study testing IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE, Proton (prostate bed) to 70.2 CGE and IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE in people with Prostate Cancer, run by Proton Collaborative Group at 6 sites in United States.
Trial summary
The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning. 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?
- IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE, Proton (prostate bed) to 70.2 CGE and IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2009to Aug 2050
- Phase
- Interventional
- 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
- Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
- Maximum PSA value of 20 ng/ml.
Who cannot join
- Evidence of distant metastasis (M1).
- Prior systemic chemotherapy for any reason.
- Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
- Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
- Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Sangeetha Moturi, 571-472-0343, sangeetha.moturi@inova.org
Kevin Choe, MD
- Recruiting
McLaren Proton Therapy Center
Flint, Michigan, 48532
Stacy Freeman, 313-576-8495, freemans@karmanos.org
Brian Yeh, MD
- Recruiting
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
Intake Coordinator, 877-686-6009
Samuel Jean-Baptiste, MD
- Recruiting
Proton Center of Arkansas
Little Rock, Arkansas, 72205
Monica Coleman, 501-686-8274, mmcoleman@uams.edu
Sanjay Maraboyina, MD
- Recruiting
Mercy David C. Pratt Cancer Center
St Louis, Missouri, 63141
Nancy Umbeck, 314-251-7066, nancy.umbeck@mercy.net
Amit Roy, MD
- 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: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.
- Conditions
- Prostate Cancer
- Being tested
- IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE, Proton (prostate bed) to 70.2 CGE, IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE, Proton to 66.6 CGE
- 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.
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGERadiation
Postop High Risk
Proton (prostate bed) to 70.2 CGERadiation
Salvage Non-High Risk
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGERadiation
Salvage High Risk
Proton to 66.6 CGERadiation
Post-Op Non High Risk
| Study group | Role | What they receive |
|---|---|---|
| Postop Non-High Risk | Experimental | Proton to 66.6 CGE Receives: Radiation: Proton to 66.6 CGE |
| Postop High Risk | Experimental | IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE Receives: Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE |
| Salvage Non-High Risk | Experimental | Proton to 70.2 CGE Receives: Radiation: Proton (prostate bed) to 70.2 CGE |
| Salvage High Risk | Experimental | IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE Receives: Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
Measured: 6 months after the end of radiation therapy
Secondary outcomes (1)
Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters
Measured: After radiation: every 6 months for 3 years, then annually for 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2031 (estimated)
- Study completionAug 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proton Collaborative Group
- Sponsor type
- Research network
- Collaborators
- University of Florida Health
- Responsible party
- Sponsor
- Investigators
- Samuel Jean-Baptiste, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969111
- Sponsor's protocol ID
- GU010-18
- Other IDs
- UFPTI 0902-PR06
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2009
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
American Cancer Society. 2007. Ref Type: Electronic Citation
Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006 Nov 15;296(19):2329-35. doi: 10.1001/jama.296.19.2329.
PubMed 17105795Bott SR, Freeman AA, Stenning S, Cohen J, Parkinson MC. Radical prostatectomy: pathology findings in 1001 cases compared with other major series and over time. BJU Int. 2005 Jan;95(1):34-9. doi: 10.1111/j.1464-410X.2005.05245.x.
PubMed 15638892Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009 Mar;181(3):956-62. doi: 10.1016/j.juro.2008.11.032. Epub 2009 Jan 23.
PubMed 19167731Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Marechal JM, Scalliet P, Haustermans K, Pierart M; European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005 Aug 13-19;366(9485):572-8. doi: 10.1016/S0140-6736(05)67101-2.
PubMed 16099293Bianco FJ Jr, Scardino PT, Eastham JA. Radical prostatectomy: long-term cancer control and recovery of sexual and urinary function ("trifecta"). Urology. 2005 Nov;66(5 Suppl):83-94. doi: 10.1016/j.urology.2005.06.116.
PubMed 16194712Stephenson AJ, Scardino PT, Kattan MW, Pisansky TM, Slawin KM, Klein EA, Anscher MS, Michalski JM, Sandler HM, Lin DW, Forman JD, Zelefsky MJ, Kestin LL, Roehrborn CG, Catton CN, DeWeese TL, Liauw SL, Valicenti RK, Kuban DA, Pollack A. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol. 2007 May 20;25(15):2035-41. doi: 10.1200/JCO.2006.08.9607.
PubMed 17513807Dearnaley DP, Hall E, Lawrence D, Huddart RA, Eeles R, Nutting CM, Gadd J, Warrington A, Bidmead M, Horwich A. Phase III pilot study of dose escalation using conformal radiotherapy in prostate cancer: PSA control and side effects. Br J Cancer. 2005 Feb 14;92(3):488-98. doi: 10.1038/sj.bjc.6602301.
PubMed 15685244Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8.
PubMed 12128107Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154.
PubMed 15718316Shipley WU, Verhey LJ, Munzenrider JE, Suit HD, Urie MM, McManus PL, Young RH, Shipley JW, Zietman AL, Biggs PJ, et al. Advanced prostate cancer: the results of a randomized comparative trial of high dose irradiation boosting with conformal protons compared with conventional dose irradiation using photons alone. Int J Radiat Oncol Biol Phys. 1995 Apr 30;32(1):3-12. doi: 10.1016/0360-3016(95)00063-5.
PubMed 7721636Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233.
PubMed 16160131Swanson GP, Hussey MA, Tangen CM, Chin J, Messing E, Canby-Hagino E, Forman JD, Thompson IM, Crawford ED; SWOG 8794. Predominant treatment failure in postprostatectomy patients is local: analysis of patterns of treatment failure in SWOG 8794. J Clin Oncol. 2007 Jun 1;25(16):2225-9. doi: 10.1200/JCO.2006.09.6495.
PubMed 17538167King CR, Kapp DS. Radiotherapy after prostatectomy: is the evidence for dose escalation out there? Int J Radiat Oncol Biol Phys. 2008 Jun 1;71(2):346-50. doi: 10.1016/j.ijrobp.2007.10.008. Epub 2008 Jan 30.
PubMed 18234451King CR, Spiotto MT. Improved outcomes with higher doses for salvage radiotherapy after prostatectomy. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):23-7. doi: 10.1016/j.ijrobp.2007.09.047. Epub 2008 Jan 22.
PubMed 18207668
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00969111
- Acronym / sponsor ID
- GU010-18
- Conditions
- Prostate Cancer
- Keywords
- Proton Radiation, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Proton Collaborative GroupResearch network
- Collaborators
- University of Florida Health
- Study start
- Aug 2009
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2050 (estimated)
- First posted
- 31 Aug 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 see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Postop Non-High Risk | Experimental | Radiation: Proton to 66.6 CGEProton to 66.6 CGE |
| Postop High Risk | Experimental | Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGEIMRT to 45 Gy; prostate bed proton boost of 21.6 CGE |
| Salvage Non-High Risk | Experimental | Radiation: Proton (prostate bed) to 70.2 CGEProton to 70.2 CGE |
| Salvage High Risk | Experimental | Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGEIMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
- Maximum PSA value of 20 ng/ml.
Key exclusion criteria (6 listed)
- Evidence of distant metastasis (M1).
- Prior systemic chemotherapy for any reason.
- Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
- Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
- Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
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 |
|---|---|---|
| IMRT to 45 Gy; prostate bed proton boost of 21.6 CGEPostop High Risk | Radiation | Postop High Risk |
| Proton (prostate bed) to 70.2 CGESalvage Non-High Risk | Radiation | Salvage Non-High Risk |
| IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGESalvage High Risk | Radiation | Salvage High Risk |
| Proton to 66.6 CGEPost-Op Non High Risk | Radiation | Postop Non-High Risk |
Primary outcome
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
Time frame: 6 months after the end of radiation therapy
1 secondary outcome
Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters
Time frame: After radiation: every 6 months for 3 years, then annually for 20 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 17 Jun 2026.
- BackgroundAmerican Cancer Society. 2007. Ref Type: Electronic Citation
- Background: PubMed 17105795Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006 Nov 15;296(19):2329-35. doi: 10.1001/jama.296.19.2329.
- Background: PubMed 15638892Bott SR, Freeman AA, Stenning S, Cohen J, Parkinson MC. Radical prostatectomy: pathology findings in 1001 cases compared with other major series and over time. BJU Int. 2005 Jan;95(1):34-9. doi: 10.1111/j.1464-410X.2005.05245.x.
- Background: PubMed 19167731Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009 Mar;181(3):956-62. doi: 10.1016/j.juro.2008.11.032. Epub 2009 Jan 23.
- Background: PubMed 16099293Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Marechal JM, Scalliet P, Haustermans K, Pierart M; European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005 Aug 13-19;366(9485):572-8. doi: 10.1016/S0140-6736(05)67101-2.
- Background: PubMed 16194712Bianco FJ Jr, Scardino PT, Eastham JA. Radical prostatectomy: long-term cancer control and recovery of sexual and urinary function ("trifecta"). Urology. 2005 Nov;66(5 Suppl):83-94. doi: 10.1016/j.urology.2005.06.116.
- Background: PubMed 17513807Stephenson AJ, Scardino PT, Kattan MW, Pisansky TM, Slawin KM, Klein EA, Anscher MS, Michalski JM, Sandler HM, Lin DW, Forman JD, Zelefsky MJ, Kestin LL, Roehrborn CG, Catton CN, DeWeese TL, Liauw SL, Valicenti RK, Kuban DA, Pollack A. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol. 2007 May 20;25(15):2035-41. doi: 10.1200/JCO.2006.08.9607.
- Background: PubMed 15685244Dearnaley DP, Hall E, Lawrence D, Huddart RA, Eeles R, Nutting CM, Gadd J, Warrington A, Bidmead M, Horwich A. Phase III pilot study of dose escalation using conformal radiotherapy in prostate cancer: PSA control and side effects. Br J Cancer. 2005 Feb 14;92(3):488-98. doi: 10.1038/sj.bjc.6602301.
- Background: PubMed 12128107Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8.
- Background: PubMed 15718316Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154.
- Background: PubMed 7721636Shipley WU, Verhey LJ, Munzenrider JE, Suit HD, Urie MM, McManus PL, Young RH, Shipley JW, Zietman AL, Biggs PJ, et al. Advanced prostate cancer: the results of a randomized comparative trial of high dose irradiation boosting with conformal protons compared with conventional dose irradiation using photons alone. Int J Radiat Oncol Biol Phys. 1995 Apr 30;32(1):3-12. doi: 10.1016/0360-3016(95)00063-5.
- Background: PubMed 16160131Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233.
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
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
Samuel Jean-Baptiste, MD principal investigator
University of Florida
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE, Proton (prostate bed) to 70.2 CGE and IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE in people with Prostate Cancer, run by Proton Collaborative Group at 6 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 2 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: looking for participants now, as of the sponsor's last update on 17 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 6 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.
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?
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy. (time frame: 6 months after the end of radiation therapy). 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 NCT00969111, which also lists 42 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 17 Jun 2026.