Cancer of the ProstateNCT03564275

Proton Boost in Prostate Cancer

A study testing Proton Boost in people with Cancer of the Prostate, run by University of Cincinnati 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

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Cancer of the Prostate
What is being tested?: Proton Boost
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 16 Apr 2018to Apr 2033
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

≥18 years of age
Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) <10) -OR-
Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20)
Life expectancy >10 yrs
Physically and mentally capable of signing the consent form of their own volition

Who cannot join

< 18 years of age
Diagnosis of high risk prostate cancer (T3 or higher, Gleason >7 and/or PSA >20)
Current or historical use of androgen deprivation therapy
Nodal positivity
Previous cancer excluding non-melanoma skin cancer
History of prostatectomy

Show all 9Show fewer

History of brachytherapy for prostate cancer
Life expectancy <10 yrs
Physically or mentally incapable of signing the consent form of their own volition

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Cincinnati
Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: Assessing the Effectiveness of Photon Therapy With a Proton Therapy Boost in the Treatment of Prostate Cancer as Compared to Photon Therapy Alone

This study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.

Conditions: Cancer of the Prostate
Being tested: Proton Boost
Keywords: Radiation Therapy, Proton Therapy
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 BoostRadiation
13-15 treatments with proton therapy given as a boost to standard of care photon therapy

Study groups in NCT03564275
Study group	Role	What they receive
Prospective Treatment Group	Experimental	Proton Boost Receives: Radiation: Proton Boost
Retrospective Comparison Group	No intervention	Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.

What is being measured

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

Hematuria - Change from baseline
Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe)
Measured: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Urinary Incontinence - Change from baseline
Common Terminology Criteria for Adverse Events - Urinary Incontinence Scale - 1(least severe) - 3 (most severe)
Measured: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Dysuria - Change from baseline
Presence or Absence
Measured: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
International Prostate Symptom Score - Change from baseline
Records patient reported urinary symptoms - Scale 1-35 - 1-7 Mild symptoms, 8-19 Moderate symptoms, 20-35 Severe symptoms
Measured: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Rectal Bleeding - Change from baseline
Common Terminology Criteria for Adverse Events - Rectal Hemorrhage Scale - 1(least severe) - 5 (most severe)
Measured: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Erectile Dysfunction - Change from baseline
Common Terminology Criteria for Adverse Events - Erectile Dysfunction Scale - 1(least severe) - 3 (most severe)
Measured: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years

Secondary outcomes (2)

Progression Free Survival
Measured by time to cancer recurrence
Measured: Monitored for 10 years after completion of radiation therapy
Overall Survival
Measured by time to cancer-related death
Measured: Monitored for 10 years after completion of radiation therapy

Timeline

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

16 Apr 2018Apr 2033

First posted20 Jun 2018
Study start16 Apr 2018
Primary completionApr 2033 (estimated)
Study completionApr 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Cancer of the ProstateStudies of the same condition, open and under way.
More trials run by University of CincinnatiThe 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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: Matched pair analysis. Each prospective patient will be matched with two historical patients based on the inclusion, exclusion and match criteria.
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03564275
Sponsor's protocol ID: 2017-1091
Status last verified: May 2025
First submitted: 18 May 2018
Last updated: 31 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Boccon-Gibod LM, Dumonceau O, Toublanc M, Ravery V, Boccon-Gibod LA. Micro-focal prostate cancer: a comparison of biopsy and radical prostatectomy specimen features. Eur Urol. 2005 Dec;48(6):895-9. doi: 10.1016/j.eururo.2005.04.033.
PubMed 16125298
Gregori A, Vieweg J, Dahm P, Paulson DF. Comparison of ultrasound-guided biopsies and prostatectomy specimens: predictive accuracy of Gleason score and tumor site. Urol Int. 2001;66(2):66-71. doi: 10.1159/000056573.
PubMed 11223746
Scales CD, Amling CL, Kane CJ, et al. Can unilateral Prostate Cancer be Reliably Predicted Based Upon Biopsy Features? J Urol. 2006; 175:373.
Schulte RT, Wood DP, Daignault S, Shah RB, Wei JT. Utility of extended pattern prostate biopsies for tumor localization: pathologic correlations after radical prostatectomy. Cancer. 2008 Oct 1;113(7):1559-65. doi: 10.1002/cncr.23781.
PubMed 18726951
Arrayeh E, Westphalen AC, Kurhanewicz J, Roach M 3rd, Jung AJ, Carroll PR, Coakley FV. Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93. doi: 10.1016/j.ijrobp.2011.11.030. Epub 2012 Feb 11.
PubMed 22331003
Pollack 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 12128107
Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530.
PubMed 16648499
Andrzejewski P, Kuess P, Knausl B, Pinker K, Georg P, Knoth J, Berger D, Kirisits C, Goldner G, Helbich T, Potter R, Georg D. Feasibility of dominant intraprostatic lesion boosting using advanced photon-, proton- or brachytherapy. Radiother Oncol. 2015 Dec;117(3):509-14. doi: 10.1016/j.radonc.2015.07.028. Epub 2015 Sep 6.
PubMed 26349588
Bossart EL, Stoyanova R, Sandler K, Studenski M, Orman A, Abramowitz M, Pollack A. Feasibility and Initial Dosimetric Findings for a Randomized Trial Using Dose-Painted Multiparametric Magnetic Resonance Imaging-Defined Targets in Prostate Cancer. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):827-34. doi: 10.1016/j.ijrobp.2016.01.052. Epub 2016 Feb 4.
PubMed 27020109
Johansson S, Astrom L, Sandin F, Isacsson U, Montelius A, Turesson I. Hypofractionated proton boost combined with external beam radiotherapy for treatment of localized prostate cancer. Prostate Cancer. 2012;2012:654861. doi: 10.1155/2012/654861. Epub 2012 Jul 8.
PubMed 22848840
Nihei K, Ogino T, Ishikura S, Kawashima M, Nishimura H, Arahira S, Onozawa M. Phase II feasibility study of high-dose radiotherapy for prostate cancer using proton boost therapy: first clinical trial of proton beam therapy for prostate cancer in Japan. Jpn J Clin Oncol. 2005 Dec;35(12):745-52. doi: 10.1093/jjco/hyi193. Epub 2005 Nov 28.
PubMed 16314345

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Effectiveness of Photon Therapy With a Proton Therapy Boost in the Treatment of Prostate Cancer as Compared to Photon Therapy Alone
ClinicalTrials.gov ID: NCT03564275
Acronym / sponsor ID: 2017-1091
Conditions: Cancer of the Prostate
Keywords: Radiation Therapy, Proton Therapy
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 10 participants (actual)
Lead sponsor: University of CincinnatiUniversity, hospital or other
Study start: 16 Apr 2018 (actual)
Primary completion: Apr 2033 (estimated)
Study completion: Apr 2033 (estimated)
First posted: 20 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: Matched pair analysis. Each prospective patient will be matched with two historical patients based on the inclusion, exclusion and match criteria.

Arm	Type	Receives
Prospective Treatment Group	Experimental	Radiation: Proton BoostProton Boost
Retrospective Comparison Group	No intervention	–Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.

Who may qualify

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

Key inclusion criteria (5 listed)

≥18 years of age
Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) <10) -OR-
Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20)
Life expectancy >10 yrs
Physically and mentally capable of signing the consent form of their own volition

Key exclusion criteria (9 listed)

< 18 years of age
Diagnosis of high risk prostate cancer (T3 or higher, Gleason >7 and/or PSA >20)
Current or historical use of androgen deprivation therapy
Nodal positivity
Previous cancer excluding non-melanoma skin 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 Boost13-15 treatments with proton therapy given as a boost to standard of care photon therapy	Radiation	Prospective Treatment Group

Primary outcome

Hematuria - Change from baseline
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe)
Urinary Incontinence - Change from baseline
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Common Terminology Criteria for Adverse Events - Urinary Incontinence Scale - 1(least severe) - 3 (most severe)
Dysuria - Change from baseline
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Presence or Absence
International Prostate Symptom Score - Change from baseline
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Records patient reported urinary symptoms - Scale 1-35 - 1-7 Mild symptoms, 8-19 Moderate symptoms, 20-35 Severe symptoms
Rectal Bleeding - Change from baseline
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Common Terminology Criteria for Adverse Events - Rectal Hemorrhage Scale - 1(least severe) - 5 (most severe)
Erectile Dysfunction - Change from baseline
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Common Terminology Criteria for Adverse Events - Erectile Dysfunction Scale - 1(least severe) - 3 (most severe)

2 secondary outcomes

Progression Free Survival
Time frame: Monitored for 10 years after completion of radiation therapy
Overall Survival
Time frame: Monitored for 10 years after completion 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 31 May 2025.
Background: PubMed 16125298Boccon-Gibod LM, Dumonceau O, Toublanc M, Ravery V, Boccon-Gibod LA. Micro-focal prostate cancer: a comparison of biopsy and radical prostatectomy specimen features. Eur Urol. 2005 Dec;48(6):895-9. doi: 10.1016/j.eururo.2005.04.033.
Background: PubMed 11223746Gregori A, Vieweg J, Dahm P, Paulson DF. Comparison of ultrasound-guided biopsies and prostatectomy specimens: predictive accuracy of Gleason score and tumor site. Urol Int. 2001;66(2):66-71. doi: 10.1159/000056573.
BackgroundScales CD, Amling CL, Kane CJ, et al. Can unilateral Prostate Cancer be Reliably Predicted Based Upon Biopsy Features? J Urol. 2006; 175:373.
Background: PubMed 18726951Schulte RT, Wood DP, Daignault S, Shah RB, Wei JT. Utility of extended pattern prostate biopsies for tumor localization: pathologic correlations after radical prostatectomy. Cancer. 2008 Oct 1;113(7):1559-65. doi: 10.1002/cncr.23781.
Background: PubMed 22331003Arrayeh E, Westphalen AC, Kurhanewicz J, Roach M 3rd, Jung AJ, Carroll PR, Coakley FV. Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93. doi: 10.1016/j.ijrobp.2011.11.030. Epub 2012 Feb 11.
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 16648499Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530.
Background: PubMed 26349588Andrzejewski P, Kuess P, Knausl B, Pinker K, Georg P, Knoth J, Berger D, Kirisits C, Goldner G, Helbich T, Potter R, Georg D. Feasibility of dominant intraprostatic lesion boosting using advanced photon-, proton- or brachytherapy. Radiother Oncol. 2015 Dec;117(3):509-14. doi: 10.1016/j.radonc.2015.07.028. Epub 2015 Sep 6.
Background: PubMed 27020109Bossart EL, Stoyanova R, Sandler K, Studenski M, Orman A, Abramowitz M, Pollack A. Feasibility and Initial Dosimetric Findings for a Randomized Trial Using Dose-Painted Multiparametric Magnetic Resonance Imaging-Defined Targets in Prostate Cancer. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):827-34. doi: 10.1016/j.ijrobp.2016.01.052. Epub 2016 Feb 4.
Background: PubMed 22848840Johansson S, Astrom L, Sandin F, Isacsson U, Montelius A, Turesson I. Hypofractionated proton boost combined with external beam radiotherapy for treatment of localized prostate cancer. Prostate Cancer. 2012;2012:654861. doi: 10.1155/2012/654861. Epub 2012 Jul 8.
Background: PubMed 16314345Nihei K, Ogino T, Ishikura S, Kawashima M, Nishimura H, Arahira S, Onozawa M. Phase II feasibility study of high-dose radiotherapy for prostate cancer using proton boost therapy: first clinical trial of proton beam therapy for prostate cancer in Japan. Jpn J Clin Oncol. 2005 Dec;35(12):745-52. doi: 10.1093/jjco/hyi193. Epub 2005 Nov 28.

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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.

William Barrett, MD principal investigator

University of Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Proton Boost in people with Cancer of the Prostate, run by University of Cincinnati 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 5 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 31 May 2025. 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.

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?

Hematuria - Change from baseline (time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years). The study lists 6 primary outcomes in all. 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 NCT03564275, which also lists 11 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 31 May 2025.