Adenocarcinoma of the ProstatePhase 2PR11NCT03624660

Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer

A Phase 2 study testing HR-A and HR-B in people with Adenocarcinoma of the Prostate, run by University of Florida at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years, men only
Conditions the study is for: Adenocarcinoma of the Prostate
What is being tested?: HR-A and HR-B
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 24 Sep 2018to Sep 2029
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 to 100 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment.
Patient must be at least 18 years at the time of consent.
Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease with histological evaluation via biopsy or repeat biopsy within 12 months prior to registration.
Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3T Tesla machine within 6 months prior to study registration.
A focal IPT must be visible on MRI within the prostate and/or seminal vesicles and this MRI must be obtained within 6 months of planning CT scan.
A biopsy of the dominant lesion is recommended but not required. If an ultrasound guided sextant biopsy was positive for prostatic adenocarcinoma in the area of the MRI identified intraprostatic lesion, this will be acceptable and another guided biopsy targeting the MRI identified disease will not be necessary.

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Patients with at least one of the following high-risk factors: cT3a-T3b OR Gleason 9-10 OR PSA > 30 OR more than 1 high-risk factors must be present: clinical stage of T3, Gleason score 8-10, or PSA 20 ng/ml or greater.
Hemoglobin must be ≥ 10 g/ml within 4 months prior to registration.
Zubrod performance status must be 0-1 within 4 months prior to registration.
If patient has child-producing potential, they must be willing to use medically acceptable contraception during treatment and must be advised to use it for at least 1 year thereafter. This is not applicable if the patient is not sexually active or has had a vasectomy.
Patients must be able to start treatment within 16 weeks of registration.

Who cannot join

T4 prostate disease on CT, MRI, or physical exam.
Patients unable to undergo MRI of the prostate.
Patients with a greater than 25% change in prostate volume from the pretreatment MRI of the prostate demonstrating the IPT and the treatment planning MRI. Patients in this case must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPT must still be visible.
IPT that is more than 75% of the prostate volume when measured on the CT simulation scan.
Evidence of distant metastasis (M1).
Patients with positive nodes on cross-sectional imaging.

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Previous prostate cancer local treatment including prostatectomy, hyperthermia, high intensity focused ultrasound, brachytherapy, external-beam radiation therapy, and/or cryotherapy.
Prior pelvic radiation therapy.
No prior myocardial infarction within the last 6 months, severe congestive heart failure, or end stage renal disease.
Active inflammatory bowel disease (diverticulitis, Crohn's disease, ulcerative colitis) affecting the rectum.
Bilateral hip replacement
Prior intrapelvic surgery. This includes the following:
Bladder surgery
Prior transurethral resection of the prostate (TURP) or laser ablation for benign prostatic hyperplasia (BPH).
Patients receiving continuous and current anticoagulation with warfarin sodium (Coumadin), heparin sodium, clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), enoxaparin sodium (Lovenox), prasugrel (Effient), ticagrelor (Brilinta), aspirin/er dipyridamole (Aggrenox), or fondaparinux sodium (Arixtra).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32206

Other trials in United States

About this study

Official title: A Phase II Study of Dose-Escalated Proton-Based Radiation Therapy Delivered With a Simultaneous Integrated Boost (SIB) to Intraprostatic Tumors (IPT) Visible on Pretreatment Magnetic Resonance Image

The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. The study features hypofractionation and a simultaneous integrated boost to the magnetic resonance imaging (MRI) identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months if the patient decides to receive ADT.

Read the detailed description

Prostate cancer is the most common noncutaneous cancer among men in the United States. The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer.

Proton therapy (PT) is a type of ionizing radiation therapy that reduces the dose of excess radiation delivered to normal tissues. By escalating the radiation dose just to the area of the known tumor within the prostate, one could potentially reduce the amount of excess radiation delivered to surrounding organs.This reduction in dose would improve the therapeutic ratio by improving disease control while minimizing the risk for additional toxicity.

In an effort to take advantage of dose escalation's potential for improving disease control but also to limit toxicity, the use of advanced imaging to identify prostate cancer and provide a focal radiation boost to the area have proven to be useful. Recent advances in MRI have made it the most promising technique in identifying and targeting IPTs, improving both cancer control rates and decreasing toxicity.

The study features hypofractionation and a simultaneous integrated boost to the MRI identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months.

Conditions: Adenocarcinoma of the Prostate
Being tested: HR-A, HR-B
Keywords: High-risk, Prostate cancer, Proton Radiation, Dose-escalated, Hypofractionation, Simultaneous Integrated Boost (SIB), Intraprostatic Tumor (IPT), Proton Therapy (PT), Androgen Deprivation Therapy (ADT), Magnetic Resonance Imaging (MRI)
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HR-ARadiation
Also called Proton Radiation
The prostate and proximal seminal vesicles will be treated to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent.
Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent.
Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.
HR-BRadiation
Also called Proton Radiation
The prostate, proximal seminal vesicles, and pelvic nodes will be treated to 2 cobalt gray equivalent per fraction for 23 fractions for a total of 46 cobalt gray equivalent.
The prostate and proximal seminal vesicles will be treated to an additional 2 cobalt gray equivalent per fraction for 16 fractions for a total of 32 cobalt gray equivalent.
Electively treat the entire uninvolved seminal vesicle to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent when part of the seminal vesicle is involved with tumor.
Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent.
Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.

Study groups in NCT03624660
Study group	Role	What they receive
HR-A (High-risk A)	Experimental	* Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent. * Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent. Receives: Radiation: HR-A
HR-B (High-risk B)	Experimental	* Prostate, proximal seminal vesicles, and pelvic nodes: 2 cobalt gray equivalent per fraction to a total does of 46 cobalt gray equivalent. * Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 32 cobalt gray equivalent. * Entire uninvolved seminal vesicle when part of the seminal vesicle is involved with tumor: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent. * Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent. Receives: Radiation: HR-B

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative rate of biochemical failure at 5 years after the end of treatment.
Biochemical failure will be defined based on the Phoenix definition. Biochemical failure has occurred if the post-treatment prostate-specific antigen (PSA) on at least two occasions rose more than 2 ng/ml above the PSA nadir. Rate of biochemical failure will be measured at 5 years after the end of treatment.
Measured: 5 years after the end of radiation therapy

Secondary outcomes (6)

Cumulative rate of acute toxicity observed between day 1 of treatment and 90 days after treatment.
Assess physician-graded, severe (Grade 3-4), acute (early, within 90 days of treatment) genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 90 days after the end of radiation therapy
Cumulative rate of late toxicity observed between 90 days and 5 years after end of treatment.
Assess physician-graded, severe (Grade 3-4), late (beginning 90 or more days after treatment), cumulative 5 year genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 60 months after the end of radiation therapy
Rate of change in sexual, bowel, and urinary function from baseline measurement to 5 years after end of treatment.
Assess changes in patient-reported quality of life before and after treatment according to The International Index of Erectile Function (IIEF-5/IIEF-5m) which measures sexual function and the effect of radiation therapy; The International Prostate Symptom Score (IPSS) which measures urinary function and the effect of radiation therapy; and The Expanded Prostate Cancer Index Composite (EPIC) which measures different areas that may be affected by prostate cancer or its treatment.
Measured: Rate of change between baseline measurement and 5 years end of radiation therapy
Assessment of overall and disease-free survival
Assess the overall survival, defined as the time from the start of treatment to the date of death of any cause, if data is available, at 5 years. Also, cause-specific survival will be calculated.
Measured: 5 years after the end of radiation therapy
Assessment of local persistence or local recurrence
Assess local persistence or local recurrence of prostate cancer at 5 years. Local persistence is defined as the failure of the original abnormal tumor mass seen on cross sectional imaging and/or found on digital rectal exam to resolve in patients who also had a poor PSA response with a PSA nadir greater than 1 ng/mL. Local recurrence is defined as the development of any new abnormal prostate mass on cross sectional imaging or on digital rectal exam with previous exams or imaging showing no mass in the area prior to radiation therapy or after initial treatment.
Measured: 5 years after the end of radiation therapy
Rate of distant metastases five years after end of radiation therapy
Assess the cumulative rate development of distant metastasis up to 5 years after end of radiation. This will be an aggregate binary, yes/no response based on evidence acquired from sources including CT scan, bone scan, and/or PET/CT scan.
Measured: 5 years after the end of radiation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 2018Sep 2029

First posted10 Aug 2018
Study start24 Sep 2018
Primary completionSep 2029 (estimated)
Study completionSep 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (59)Papers the sponsor has linked to this study.
Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
More trials run by University of FloridaThe 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: Non-randomised
Intervention model: Parallel groups
Model description: Patients will be assigned to treatment group according to their lymph node risk or seminal vesicle invasion. 2 treatment groups: * HR-A: Patients with \<15% risk of positive pelvic nodes, without posterior extracapsular extension and negative for seminal vesicle invasion on exam pretreatment diagnostic MRI. * HR-B: Patient with ≥ 15% risk of positive pelvic nodes or with seminal vesicle invasion, without posterior extracapsular extension.
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03624660
Sponsor's protocol ID: IRB201800933
Other IDs: UFPTI 1712-PR11, OCR17697
Acronym: PR11
Status last verified: Jun 2026
First submitted: 23 Jul 2018
Last updated: 13 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

American Joint Committee on Cancer. AJCC Cancer Staging Manual. 8thedition ed. New York, NY: Springer; 2017.
Bryant C, Smith TL, Henderson RH, Hoppe BS, Mendenhall WM, Nichols RC, Morris CG, Williams CR, Su Z, Li Z, Lee D, Mendenhall NP. Five-Year Biochemical Results, Toxicity, and Patient-Reported Quality of Life After Delivery of Dose-Escalated Image Guided Proton Therapy for Prostate Cancer. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):422-434. doi: 10.1016/j.ijrobp.2016.02.038. Epub 2016 Feb 16.
PubMed 27084658
Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.
PubMed 17765406
Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.
PubMed 17482880
Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, Bush DA, Lunt M, Spiegel DY, Skowronski R, Jabola BR, Rossi CJ. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09. J Clin Oncol. 2010 Mar 1;28(7):1106-11. doi: 10.1200/JCO.2009.25.8475. Epub 2010 Feb 1.
PubMed 20124169
Beckendorf V, Guerif S, Le Prise E, Cosset JM, Lefloch O, Chauvet B, Salem N, Chapet O, Bourdin S, Bachaud JM, Maingon P, Lagrange JL, Malissard L, Simon JM, Pommier P, Hay MH, Dubray B, Luporsi E, Bey P. The GETUG 70 Gy vs. 80 Gy randomized trial for localized prostate cancer: feasibility and acute toxicity. Int J Radiat Oncol Biol Phys. 2004 Nov 15;60(4):1056-65. doi: 10.1016/j.ijrobp.2004.05.033.
PubMed 15519775
Rodda S, Tyldesley S, Morris WJ, Keyes M, Halperin R, Pai H, McKenzie M, Duncan G, Morton G, Hamm J, Murray N. ASCENDE-RT: An Analysis of Treatment-Related Morbidity for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost with a Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):286-295. doi: 10.1016/j.ijrobp.2017.01.008. Epub 2017 Jan 6.
PubMed 28433432
Ippolito E, Mantini G, Morganti AG, Mazzeo E, Padula GD, Digesu C, Cilla S, Frascino V, Luzi S, Massaccesi M, Macchia G, Deodato F, Mattiucci GC, Piermattei A, Cellini N. Intensity-modulated radiotherapy with simultaneous integrated boost to dominant intraprostatic lesion: preliminary report on toxicity. Am J Clin Oncol. 2012 Apr;35(2):158-62. doi: 10.1097/COC.0b013e318209cd8f.
PubMed 21336090
Fonteyne V, Villeirs G, Speleers B, De Neve W, De Wagter C, Lumen N, De Meerleer G. Intensity-modulated radiotherapy as primary therapy for prostate cancer: report on acute toxicity after dose escalation with simultaneous integrated boost to intraprostatic lesion. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):799-807. doi: 10.1016/j.ijrobp.2008.01.040. Epub 2008 Apr 11.
PubMed 18407430
Cellini N, Morganti AG, Mattiucci GC, Valentini V, Leone M, Luzi S, Manfredi R, Dinapoli N, Digesu' C, Smaniotto D. Analysis of intraprostatic failures in patients treated with hormonal therapy and radiotherapy: implications for conformal therapy planning. Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):595-9. doi: 10.1016/s0360-3016(02)02795-5.
PubMed 12062602
Pucar D, Hricak H, Shukla-Dave A, Kuroiwa K, Drobnjak M, Eastham J, Scardino PT, Zelefsky MJ. Clinically significant prostate cancer local recurrence after radiation therapy occurs at the site of primary tumor: magnetic resonance imaging and step-section pathology evidence. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):62-9. doi: 10.1016/j.ijrobp.2007.03.065.
PubMed 17707266
Pokorny MR, de Rooij M, Duncan E, Schroder FH, Parkinson R, Barentsz JO, Thompson LC. Prospective study of diagnostic accuracy comparing prostate cancer detection by transrectal ultrasound-guided biopsy versus magnetic resonance (MR) imaging with subsequent MR-guided biopsy in men without previous prostate biopsies. Eur Urol. 2014 Jul;66(1):22-9. doi: 10.1016/j.eururo.2014.03.002. Epub 2014 Mar 14.
PubMed 24666839
Van Vulpen M, Van Loon J, Pos F, et al. OC-0282: FLAME randomised trial: 95Gy MRI-boost vs 77Gy prostate radiotherapy: toxicity and quality of life. Radiother Oncol. 2016;119(1 Suppl):S132.
Pollack A, Walker G, Horwitz EM, Price R, Feigenberg S, Konski AA, Stoyanova R, Movsas B, Greenberg RE, Uzzo RG, Ma C, Buyyounouski MK. Randomized trial of hypofractionated external-beam radiotherapy for prostate cancer. J Clin Oncol. 2013 Nov 1;31(31):3860-8. doi: 10.1200/JCO.2013.51.1972. Epub 2013 Oct 7.
PubMed 24101042
American Cancer Society. Cancer Facts & Figures 2016. 2016; https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2016.html. Accessed 10/03/2017.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Dose-Escalated Proton-Based Radiation Therapy Delivered With a Simultaneous Integrated Boost (SIB) to Intraprostatic Tumors (IPT) Visible on Pretreatment Magnetic Resonance Image
ClinicalTrials.gov ID: NCT03624660
Acronym / sponsor ID: PR11 / IRB201800933
Conditions: Adenocarcinoma of the Prostate
Keywords: High-risk, Prostate cancer, Proton Radiation, Dose-escalated, Hypofractionation, Simultaneous Integrated Boost (SIB), Intraprostatic Tumor (IPT), Proton Therapy (PT)
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: 24 Sep 2018 (actual)
Primary completion: Sep 2029 (estimated)
Study completion: Sep 2029 (estimated)
First posted: 10 Aug 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients will be assigned to treatment group according to their lymph node risk or seminal vesicle invasion. 2 treatment groups: * HR-A: Patients with <15% risk of positive pelvic nodes, without posterior extracapsular extension and negative for seminal vesicle invasion on exam pretreatment diagnostic MRI. * HR-B: Patient with ≥ 15% risk of positive pelvic nodes or with seminal vesicle invasion, without posterior extracapsular extension.

Arm	Type	Receives
HR-A (High-risk A)	Experimental	Radiation: HR-A* Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent. * Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.
HR-B (High-risk B)	Experimental	Radiation: HR-B* Prostate, proximal seminal vesicles, and pelvic nodes: 2 cobalt gray equivalent per fraction to a total does of 46 cobalt gray equivalent. * Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 32 cobalt gray equivalent. * Entire uninvolved seminal vesicle when part of the seminal vesicle is involved with tumor: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent. * Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.

Who may qualify

Ages: 18 to 100 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patient must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment.
Patient must be at least 18 years at the time of consent.
Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease with histological evaluation via biopsy or repeat biopsy within 12 months prior to registration.
Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3T Tesla machine within 6 months prior to study registration.
A focal IPT must be visible on MRI within the prostate and/or seminal vesicles and this MRI must be obtained within 6 months of planning CT scan.

Key exclusion criteria (15 listed)

T4 prostate disease on CT, MRI, or physical exam.
Patients unable to undergo MRI of the prostate.
Patients with a greater than 25% change in prostate volume from the pretreatment MRI of the prostate demonstrating the IPT and the treatment planning MRI. Patients in this case must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPT must still be visible.
IPT that is more than 75% of the prostate volume when measured on the CT simulation scan.
Evidence of distant metastasis (M1).

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
HR-AAlso: Proton RadiationThe prostate and proximal seminal vesicles will be treated to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent. Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent. Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.	Radiation	HR-A (High-risk A)
HR-BAlso: Proton RadiationThe prostate, proximal seminal vesicles, and pelvic nodes will be treated to 2 cobalt gray equivalent per fraction for 23 fractions for a total of 46 cobalt gray equivalent. The prostate and proximal seminal vesicles will be treated to an additional 2 cobalt gray equivalent per fraction for 16 fractions for a total of 32 cobalt gray equivalent. Electively treat the entire uninvolved seminal vesicle to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent when part of the seminal vesicle is involved with tumor. Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent. Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.	Radiation	HR-B (High-risk B)

Primary outcome

Cumulative rate of biochemical failure at 5 years after the end of treatment.
Time frame: 5 years after the end of radiation therapy
Biochemical failure will be defined based on the Phoenix definition. Biochemical failure has occurred if the post-treatment prostate-specific antigen (PSA) on at least two occasions rose more than 2 ng/ml above the PSA nadir. Rate of biochemical failure will be measured at 5 years after the end of treatment.

6 secondary outcomes

Cumulative rate of acute toxicity observed between day 1 of treatment and 90 days after treatment.
Time frame: 90 days after the end of radiation therapy
Cumulative rate of late toxicity observed between 90 days and 5 years after end of treatment.
Time frame: 60 months after the end of radiation therapy
Rate of change in sexual, bowel, and urinary function from baseline measurement to 5 years after end of treatment.
Time frame: Rate of change between baseline measurement and 5 years end of radiation therapy
Assessment of overall and disease-free survival
Time frame: 5 years after the end of radiation therapy
Assessment of local persistence or local recurrence
Time frame: 5 years after the end of radiation therapy
Rate of distant metastases five years after end of radiation therapy
Time frame: 5 years after the end of radiation therapy

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 13 Aug 2026.
BackgroundAmerican Joint Committee on Cancer. AJCC Cancer Staging Manual. 8thedition ed. New York, NY: Springer; 2017.
Background: PubMed 27084658Bryant C, Smith TL, Henderson RH, Hoppe BS, Mendenhall WM, Nichols RC, Morris CG, Williams CR, Su Z, Li Z, Lee D, Mendenhall NP. Five-Year Biochemical Results, Toxicity, and Patient-Reported Quality of Life After Delivery of Dose-Escalated Image Guided Proton Therapy for Prostate Cancer. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):422-434. doi: 10.1016/j.ijrobp.2016.02.038. Epub 2016 Feb 16.
Background: PubMed 17765406Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.
Background: PubMed 17482880Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.
Background: PubMed 20124169Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, Bush DA, Lunt M, Spiegel DY, Skowronski R, Jabola BR, Rossi CJ. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09. J Clin Oncol. 2010 Mar 1;28(7):1106-11. doi: 10.1200/JCO.2009.25.8475. Epub 2010 Feb 1.
Background: PubMed 15519775Beckendorf V, Guerif S, Le Prise E, Cosset JM, Lefloch O, Chauvet B, Salem N, Chapet O, Bourdin S, Bachaud JM, Maingon P, Lagrange JL, Malissard L, Simon JM, Pommier P, Hay MH, Dubray B, Luporsi E, Bey P. The GETUG 70 Gy vs. 80 Gy randomized trial for localized prostate cancer: feasibility and acute toxicity. Int J Radiat Oncol Biol Phys. 2004 Nov 15;60(4):1056-65. doi: 10.1016/j.ijrobp.2004.05.033.
Background: PubMed 28433432Rodda S, Tyldesley S, Morris WJ, Keyes M, Halperin R, Pai H, McKenzie M, Duncan G, Morton G, Hamm J, Murray N. ASCENDE-RT: An Analysis of Treatment-Related Morbidity for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost with a Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):286-295. doi: 10.1016/j.ijrobp.2017.01.008. Epub 2017 Jan 6.
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Contact the University of Florida Health Proton Therapy InstituteLink 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.

Curtis M Bryant, MD, MPH principal investigator

University of Florida Health Proton Therapy Institute

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 HR-A and HR-B in people with Adenocarcinoma of the Prostate, run by University of Florida 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 11 inclusion and 15 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 13 Aug 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 rate of biochemical failure at 5 years after the end of treatment. (time frame: 5 years 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 NCT03624660, which also lists 59 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 13 Aug 2026.