NCT00831623

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
19 days until next milestone

Study Start

First participant enrolled

February 17, 2009

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2019

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

March 13, 2023

Completed
Last Updated

March 13, 2023

Status Verified

February 1, 2023

Enrollment Period

10.4 years

First QC Date

January 28, 2009

Results QC Date

June 15, 2021

Last Update Submit

February 14, 2023

Conditions

Prostate Cancer

Keywords

hypofractionationproton beam radiation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

Study Arms (1)

Proton radiation therapy

EXPERIMENTAL

Single arm

Radiation: Proton RadiationRadiation: Proton

Interventions

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)

Proton radiation therapy
ProtonRADIATION

As above

Also known as: Proton Radiation treatment
Proton radiation therapy

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsTreatment for prostate cancer in males
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior or concurrent invasive malignancy
  • Evidence of distant metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Loma Linda, California, 92354, United States

Location

Related Publications (13)

  • 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.

    PMID: 16160131BACKGROUND

  • 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.

    PMID: 15491710BACKGROUND

  • 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.

    PMID: 15145147BACKGROUND

  • 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.

    PMID: 24066950BACKGROUND

  • 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.

    PMID: 20932675BACKGROUND

  • 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.

    PMID: 20233822BACKGROUND

  • 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.

    PMID: 20124169BACKGROUND

  • 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.

    PMID: 16551128BACKGROUND

  • 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.

    PMID: 16488552BACKGROUND

  • 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.

    PMID: 10223493BACKGROUND

  • 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.

    PMID: 9788407BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 31773043RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Proton TherapyProtons

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeuticsCations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical Phenomena

Results Point of Contact

Title
Dr. Jason Slater
Organization
LomaLindaU
jaslater@llu.edu
909-558-4243

Study Officials

  • Jerry D Slater, MD

    Loma Linda University Medical Center Dept. of Radiation Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair Department of Radiation Medicine

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

February 17, 2009

Primary Completion

July 18, 2019

Study Completion

July 18, 2019

Last Updated

March 13, 2023

Results First Posted

March 13, 2023

Record last verified: 2023-02

Locations

US(1)