NCT00693238

Brief Summary

The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2008

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

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 24, 2013

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

4.2 years

First QC Date

June 4, 2008

Results QC Date

March 14, 2013

Last Update Submit

September 15, 2023

Conditions

Prostate Cancer

Keywords

Prostate CancerProton Radiation

Outcome Measures

Primary Outcomes (1)

  • Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.

    6 months after the end of radiation therapy

Secondary Outcomes (1)

  • Disease Control

    20 years after end of radiation

Study Arms (2)

Low Risk Proton Radiation

EXPERIMENTAL

70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx

Radiation: Low Risk Proton Radiation

Intermediate Risk Proton Radiation

EXPERIMENTAL

72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx

Radiation: Intermediate Risk Proton Radiation

Interventions

Low Risk Proton RadiationRADIATION
Low Risk Proton Radiation
Intermediate Risk Proton RadiationRADIATION
Intermediate Risk Proton Radiation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer.
  • Gleason score 2-7.
  • PSA ≤ 20 ng/ml.

You may not qualify if:

  • Previous prostate cancer surgery or pelvic radiation.
  • Prior or current chemotherapy for prostate cancer.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
  • History of proximal urethral stricture requiring dilatation.
  • History of hip replacement.
  • Diabetes requiring medication.
  • Prior intrapelvic surgery.
  • Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
  • On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (29)

  • American Cancer Society. 2007. Ref Type: Electronic Citation

    BACKGROUND

  • Soloway MS, Pareek K, Sharifi R, Wajsman Z, McLeod D, Wood DP Jr, Puras-Baez A; Lupron Depot Neoadjuvant Prostate Cancer Study Group. Neoadjuvant androgen ablation before radical prostatectomy in cT2bNxMo prostate cancer: 5-year results. J Urol. 2002 Jan;167(1):112-6.

    PMID: 11743286BACKGROUND

  • Hull GW, Rabbani F, Abbas F, Wheeler TM, Kattan MW, Scardino PT. Cancer control with radical prostatectomy alone in 1,000 consecutive patients. J Urol. 2002 Feb;167(2 Pt 1):528-34. doi: 10.1016/S0022-5347(01)69079-7.

    PMID: 11792912BACKGROUND

  • Kestin LL, Martinez AA, Stromberg JS, Edmundson GK, Gustafson GS, Brabbins DS, Chen PY, Vicini FA. Matched-pair analysis of conformal high-dose-rate brachytherapy boost versus external-beam radiation therapy alone for locally advanced prostate cancer. J Clin Oncol. 2000 Aug;18(15):2869-80. doi: 10.1200/JCO.2000.18.15.2869.

    PMID: 10920135BACKGROUND

  • Merrick GS, Butler WM, Wallner KE, Galbreath RW, Allen ZA, Adamovich E. The impact of primary Gleason grade on biochemical outcome following brachytherapy for hormone-naive Gleason score 7 prostate cancer. Cancer J. 2005 May-Jun;11(3):234-40. doi: 10.1097/00130404-200505000-00010.

    PMID: 16053667BACKGROUND

  • Demanes DJ, Rodriguez RR, Schour L, Brandt D, Altieri G. High-dose-rate intensity-modulated brachytherapy with external beam radiotherapy for prostate cancer: California endocurietherapy's 10-year results. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1306-16. doi: 10.1016/j.ijrobp.2004.08.014.

    PMID: 15817332BACKGROUND

  • D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.

    PMID: 9749478BACKGROUND

  • Common Terminology Criteria for Adverse Events v3.0 (CTCAE). National Cancer Institute. 12-12-0003. 9-9-0005. Ref Type: Electronic Citation

    BACKGROUND

  • Chism DB, Hanlon AL, Horwitz EM, Feigenberg SJ, Pollack A. A comparison of the single and double factor high-risk models for risk assignment of prostate cancer treated with 3D conformal radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):380-5. doi: 10.1016/j.ijrobp.2003.10.059.

    PMID: 15145151BACKGROUND

  • Martinez AA, Demanes DJ, Galalae R, Vargas C, Bertermann H, Rodriguez R, Gustafson G, Altieri G, Gonzalez J. Lack of benefit from a short course of androgen deprivation for unfavorable prostate cancer patients treated with an accelerated hypofractionated regime. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1322-31. doi: 10.1016/j.ijrobp.2004.12.053.

    PMID: 16029788BACKGROUND

  • Roach M, Lu J, Pilepich MV, Asbell SO, Mohiuddin M, Terry R, Grignon D. Four prognostic groups predict long-term survival from prostate cancer following radiotherapy alone on Radiation Therapy Oncology Group clinical trials. Int J Radiat Oncol Biol Phys. 2000 Jun 1;47(3):609-15. doi: 10.1016/s0360-3016(00)00578-2.

    PMID: 10837943BACKGROUND

  • Ghilezan MJ, Jaffray DA, Siewerdsen JH, Van Herk M, Shetty A, Sharpe MB, Zafar Jafri S, Vicini FA, Matter RC, Brabbins DS, Martinez AA. Prostate gland motion assessed with cine-magnetic resonance imaging (cine-MRI). Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):406-17. doi: 10.1016/j.ijrobp.2003.10.017.

    PMID: 15890582BACKGROUND

  • Padhani AR, Khoo VS, Suckling J, Husband JE, Leach MO, Dearnaley DP. Evaluating the effect of rectal distension and rectal movement on prostate gland position using cine MRI. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):525-33. doi: 10.1016/s0360-3016(99)00040-1.

    PMID: 10348281BACKGROUND

  • Litzenberg D, Dawson LA, Sandler H, Sanda MG, McShan DL, Ten Haken RK, Lam KL, Brock KK, Balter JM. Daily prostate targeting using implanted radiopaque markers. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):699-703. doi: 10.1016/s0360-3016(01)02654-2.

    PMID: 11849792BACKGROUND

  • Litzenberg DW, Balter JM, Hadley SW, Sandler HM, Willoughby TR, Kupelian PA, Levine L. Influence of intrafraction motion on margins for prostate radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):548-53. doi: 10.1016/j.ijrobp.2005.12.033. Epub 2006 Mar 20.

    PMID: 16545919BACKGROUND

  • Vargas C, Yan D, Kestin LL, Krauss D, Lockman DM, Brabbins DS, Martinez AA. Phase II dose escalation study of image-guided adaptive radiotherapy for prostate cancer: use of dose-volume constraints to achieve rectal isotoxicity. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):141-9. doi: 10.1016/j.ijrobp.2004.12.017.

    PMID: 16111582BACKGROUND

  • Vargas C, Martinez A, Kestin LL, Yan D, Grills I, Brabbins DS, Lockman DM, Liang J, Gustafson GS, Chen PY, Vicini FA, Wong JW. Dose-volume analysis of predictors for chronic rectal toxicity after treatment of prostate cancer with adaptive image-guided radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1297-308. doi: 10.1016/j.ijrobp.2004.12.052.

    PMID: 16029785BACKGROUND

  • Dearnaley 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.

    PMID: 15685244BACKGROUND

  • 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.

    PMID: 12128107BACKGROUND

  • Sathya 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.

    PMID: 15718316BACKGROUND

  • Shipley 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.

    PMID: 7721636BACKGROUND

  • Vargas, C, Martinez, A, and Boike, T. Long term survival benefit of a prospective dose escalation trial using high dose rate (HDR) brachytherapy boost. Int.J.Radiat.Oncol.Biol.Phys.2005. Ref Type: Abstract

    BACKGROUND

  • Vargas C, Martinez A, Galalae R, Demanes J, Harsolia A, Schour L, Nuernberg N, Gonzalez J. High-dose radiation employing external beam radiotherapy and high-dose rate brachytherapy with and without neoadjuvant androgen deprivation for prostate cancer patients with intermediate- and high-risk features. Prostate Cancer Prostatic Dis. 2006;9(3):245-53. doi: 10.1038/sj.pcan.4500882. Epub 2006 Jun 20.

    PMID: 16786040BACKGROUND

  • 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

  • Kupelian PA, Reddy CA, Klein EA, Willoughby TR. Short-course intensity-modulated radiotherapy (70 GY at 2.5 GY per fraction) for localized prostate cancer: preliminary results on late toxicity and quality of life. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):988-93. doi: 10.1016/s0360-3016(01)01730-8.

    PMID: 11704322BACKGROUND

  • Kupelian PA, Reddy CA, Carlson TP, Altsman KA, Willoughby TR. Preliminary observations on biochemical relapse-free survival rates after short-course intensity-modulated radiotherapy (70 Gy at 2.5 Gy/fraction) for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):904-12. doi: 10.1016/s0360-3016(02)02836-5.

    PMID: 12095556BACKGROUND

  • Kupelian PA, Thakkar VV, Khuntia D, Reddy CA, Klein EA, Mahadevan A. Hypofractionated intensity-modulated radiotherapy (70 gy at 2.5 Gy per fraction) for localized prostate cancer: long-term outcomes. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1463-8. doi: 10.1016/j.ijrobp.2005.05.054. Epub 2005 Sep 19.

    PMID: 16169683BACKGROUND

  • 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

  • Henderson RH, Bryant C, Hoppe BS, Nichols RC, Mendenhall WM, Flampouri S, Su Z, Li Z, Morris CG, Mendenhall NP. Five-year outcomes from a prospective trial of image-guided accelerated hypofractionated proton therapy for prostate cancer. Acta Oncol. 2017 Jul;56(7):963-970. doi: 10.1080/0284186X.2017.1287946. Epub 2017 Feb 22.

    PMID: 28514929DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Randal Henderson, MD, MBA
Organization
University of Florida
rhenderson@floridaproton.org
904-588-1800

Study Officials

  • Randal H Henderson, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2012

Study Completion

April 25, 2022

Last Updated

September 18, 2023

Results First Posted

July 24, 2013

Record last verified: 2023-09

Locations

US(1)