Prostate CancerNCT00831623

Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

A study testing Proton Radiation and Proton in people with Prostate Cancer, run by Loma Linda University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Proton Radiation and Proton
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 167 participants
Where: 1 siteUnited States
Study dates: 17 Feb 2009to 18 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 adenocarcinoma within 180 days of registration
History \& Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration
Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
Clinical stage, Tumor Stage (T1-T2C)
Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration

Who cannot join

Prior or concurrent invasive malignancy
Evidence of distant metastasis

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda University Medical Center / James M. Slater Proton Treatment Center
Loma Linda, California, 92354

Other trials in United States

About this study

Official title: Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer

Read the detailed description

Radiation therapy has a long and established role in the curative treatment of organ-confined prostate cancer. However, the optimal radiation dose and treatment schedule remain unknown. The use of hypofractionation has a long and generally successful history in conformal proton beam therapy. Several reports detailing the efficacy and safety of hypofractionated conformal radiation therapy (with x-rays) of prostate cancer can be found in the literature. Hypofractionated conformal proton beam radiation therapy has become our institutional routine for the treatment of numerous solid tumors. The purpose of this study is to determine if a shortened overall treatment schedule will result in equivalent tumor control rates and no increased side effects as compared to our current institutional standard treatment of an equivalent dose given over a longer period of time.

Conditions: Prostate Cancer
Being tested: Proton Radiation, Proton
Keywords: hypofractionation, proton beam radiation
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 RadiationRadiation
3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions)
ProtonRadiation
Also called Proton Radiation treatment
As above

Study groups in NCT00831623
Study group	Role	What they receive
Proton radiation therapy	Experimental	Single arm Receives: Radiation: Proton Radiation; Radiation: Proton

What is being measured

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

Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0
To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.
Measured: Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years

Secondary outcomes (1)

Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0
To determine if late CTCAE version 4.0 Grade 2 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.
Measured: Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years

Timeline

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

17 Feb 200918 Jul 2019

First posted29 Jan 2009 (estimated)
Study start17 Feb 2009
Primary completion18 Jul 2019
Study completion18 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00831623
Sponsor's protocol ID: 58116
Status last verified: Feb 2023
First submitted: 28 Jan 2009
Last updated: 13 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Zietman 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 16160131
Rossi CJ Jr, Slater JD, Yonemoto LT, Jabola BR, Bush DA, Levy RP, Grove R, Slater JM. Influence of patient age on biochemical freedom from disease in patients undergoing conformal proton radiotherapy of organ-confined prostate cancer. Urology. 2004 Oct;64(4):729-32. doi: 10.1016/j.urology.2004.04.043.
PubMed 15491710
Slater JD, Rossi CJ Jr, Yonemoto LT, Bush DA, Jabola BR, Levy RP, Grove RI, Preston W, Slater JM. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):348-52. doi: 10.1016/j.ijrobp.2003.10.011.
PubMed 15145147
Slater JM, Bush DA, Grove R, Slater JD. The prognostic value of percentage of positive biopsy cores, percentage of cancer volume, and maximum involvement of biopsy cores in prostate cancer patients receiving proton and photon beam therapy. Technol Cancer Res Treat. 2014 Jun;13(3):227-31. doi: 10.7785/tcrtexpress.2013.600271. Epub 2013 Sep 20.
PubMed 24066950
Coen JJ, Bae K, Zietman AL, Patel B, Shipley WU, Slater JD, Rossi CJ. Acute and late toxicity after dose escalation to 82 GyE using conformal proton radiation for localized prostate cancer: initial report of American College of Radiology Phase II study 03-12. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1005-9. doi: 10.1016/j.ijrobp.2010.06.047. Epub 2010 Oct 6.
PubMed 20932675
Talcott JA, Rossi C, Shipley WU, Clark JA, Slater JD, Niemierko A, Zietman AL. Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer. JAMA. 2010 Mar 17;303(11):1046-53. doi: 10.1001/jama.2010.287.
PubMed 20233822
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
Slater JD. Clinical applications of proton radiation treatment at Loma Linda University: review of a fifteen-year experience. Technol Cancer Res Treat. 2006 Apr;5(2):81-9. doi: 10.1177/153303460600500202.
PubMed 16551128
Ronson BB, Yonemoto LT, Rossi CJ, Slater JM, Slater JD. Patient tolerance of rectal balloons in conformal radiation treatment of prostate cancer. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1367-70. doi: 10.1016/j.ijrobp.2005.11.001. Epub 2006 Feb 20.
PubMed 16488552
Slater JD, Rossi CJ Jr, Yonemoto LT, Reyes-Molyneux NJ, Bush DA, Antoine JE, Miller DW, Teichman SL, Slater JM. Conformal proton therapy for early-stage prostate cancer. Urology. 1999 May;53(5):978-84. doi: 10.1016/s0090-4295(99)00014-x.
PubMed 10223493
Slater JD, Yonemoto LT, Rossi CJ Jr, Reyes-Molyneux NJ, Bush DA, Antoine JE, Loredo LN, Schulte RW, Teichman SL, Slater JM. Conformal proton therapy for prostate carcinoma. Int J Radiat Oncol Biol Phys. 1998 Sep 1;42(2):299-304. doi: 10.1016/s0360-3016(98)00225-9.
PubMed 9788407
Slater JD. Twenty years of proton radiation therapy at Loma Linda University Medical Center. In U. Linz, editor. Ion beam therapy: fundamentals, technology, clinical applications. Berlin: Springer, 2012:581-595.
Slater JM, Slater JD, Kang JI, Namihas IC, Jabola BR, Brown K, Grove R, Watt C, Bush DA. Hypofractionated Proton Therapy in Early Prostate Cancer: Results of a Phase I/II Trial at Loma Linda University. Int J Part Ther. 2019 Summer;6(1):1-9. doi: 10.14338/IJPT-19-00057. Epub 2019 Aug 6.
PubMed 31773043

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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer
ClinicalTrials.gov ID: NCT00831623
Acronym / sponsor ID: 58116
Conditions: Prostate Cancer
Keywords: hypofractionation, proton beam radiation
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 17 Feb 2009 (actual)
Primary completion: 18 Jul 2019 (actual)
Study completion: 18 Jul 2019 (actual)
First posted: 29 Jan 2009 (estimated)
Results: Posted 13 Mar 2023

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Proton radiation therapy	Experimental	Radiation: Proton Radiation, Radiation: ProtonSingle arm

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)

Histologically confirmed adenocarcinoma within 180 days of registration
History \& Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration
Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
Clinical stage, Tumor Stage (T1-T2C)
Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration

Key exclusion criteria (2 listed)

Prior or concurrent invasive malignancy
Evidence of distant metastasis

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 Radiation3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions)	Radiation	Proton radiation therapy
ProtonAlso: Proton Radiation treatmentAs above	Radiation	Proton radiation therapy

Primary outcome

Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0
Time frame: Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years
To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.

1 secondary outcome

Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0
Time frame: Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years

Results and safety

Results posted to the registry on 13 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Proton Radiation Therapy	167	145

Primary outcome: Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0

Time frame: Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years. Count of participants. Unit: Participants

Measure	Proton Radiation Therapy n = 146
Value	1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Patients toxicity was assessed at 6 month intervals following completion of treatment through the duration of the trial for a minimum of 2 years, with an average of 5 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Proton Radiation Therapy	1 of 146 (0.7%)	20 of 146 (13.7%)	0 of 146

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Background: PubMed 15491710Rossi CJ Jr, Slater JD, Yonemoto LT, Jabola BR, Bush DA, Levy RP, Grove R, Slater JM. Influence of patient age on biochemical freedom from disease in patients undergoing conformal proton radiotherapy of organ-confined prostate cancer. Urology. 2004 Oct;64(4):729-32. doi: 10.1016/j.urology.2004.04.043.
Background: PubMed 15145147Slater JD, Rossi CJ Jr, Yonemoto LT, Bush DA, Jabola BR, Levy RP, Grove RI, Preston W, Slater JM. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):348-52. doi: 10.1016/j.ijrobp.2003.10.011.
Background: PubMed 24066950Slater JM, Bush DA, Grove R, Slater JD. The prognostic value of percentage of positive biopsy cores, percentage of cancer volume, and maximum involvement of biopsy cores in prostate cancer patients receiving proton and photon beam therapy. Technol Cancer Res Treat. 2014 Jun;13(3):227-31. doi: 10.7785/tcrtexpress.2013.600271. Epub 2013 Sep 20.
Background: PubMed 20932675Coen JJ, Bae K, Zietman AL, Patel B, Shipley WU, Slater JD, Rossi CJ. Acute and late toxicity after dose escalation to 82 GyE using conformal proton radiation for localized prostate cancer: initial report of American College of Radiology Phase II study 03-12. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1005-9. doi: 10.1016/j.ijrobp.2010.06.047. Epub 2010 Oct 6.
Background: PubMed 20233822Talcott JA, Rossi C, Shipley WU, Clark JA, Slater JD, Niemierko A, Zietman AL. Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer. JAMA. 2010 Mar 17;303(11):1046-53. doi: 10.1001/jama.2010.287.
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 16551128Slater JD. Clinical applications of proton radiation treatment at Loma Linda University: review of a fifteen-year experience. Technol Cancer Res Treat. 2006 Apr;5(2):81-9. doi: 10.1177/153303460600500202.
Background: PubMed 16488552Ronson BB, Yonemoto LT, Rossi CJ, Slater JM, Slater JD. Patient tolerance of rectal balloons in conformal radiation treatment of prostate cancer. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1367-70. doi: 10.1016/j.ijrobp.2005.11.001. Epub 2006 Feb 20.
Background: PubMed 10223493Slater JD, Rossi CJ Jr, Yonemoto LT, Reyes-Molyneux NJ, Bush DA, Antoine JE, Miller DW, Teichman SL, Slater JM. Conformal proton therapy for early-stage prostate cancer. Urology. 1999 May;53(5):978-84. doi: 10.1016/s0090-4295(99)00014-x.
Background: PubMed 9788407Slater JD, Yonemoto LT, Rossi CJ Jr, Reyes-Molyneux NJ, Bush DA, Antoine JE, Loredo LN, Schulte RW, Teichman SL, Slater JM. Conformal proton therapy for prostate carcinoma. Int J Radiat Oncol Biol Phys. 1998 Sep 1;42(2):299-304. doi: 10.1016/s0360-3016(98)00225-9.
BackgroundSlater JD. Twenty years of proton radiation therapy at Loma Linda University Medical Center. In U. Linz, editor. Ion beam therapy: fundamentals, technology, clinical applications. Berlin: Springer, 2012:581-595.

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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.

Jerry D Slater, MD principal investigator

Loma Linda University Medical Center Dept. of Radiation Medicine

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 Radiation and Proton in people with Prostate Cancer, run by Loma Linda University 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 2 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: finished, as of the sponsor's last update on 13 Mar 2023. 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?

Yes. Results are posted in the registry (first posted 13 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 (time frame: Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years). 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 NCT00831623, which also lists 13 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 Mar 2023.