PR04: Proton Therapy for Low and Intermediate Risk Prostate Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
Low Risk - Total of 70 Gy/CGE over 28 treatments
Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Low Risk Proton Radiation 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx |
Radiation: Low Risk Proton Radiation
|
Experimental: Intermediate Risk Proton Radiation 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx |
Radiation: Intermediate Risk Proton Radiation
|
Outcome Measures
Primary Outcome Measures
- Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. [6 months after the end of radiation therapy]
Secondary Outcome Measures
- Disease Control [20 years after end of radiation]
Eligibility Criteria
Criteria
Inclusion Criteria
-
Prostate cancer.
-
Gleason score 2-7.
-
PSA ≤ 20 ng/ml.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Florida Proton Therapy Institute | Jacksonville | Florida | United States | 32206 |
Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: Randal H Henderson, MD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
- American Cancer Society. 2007. Ref Type: Electronic Citation
- 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.
- Common Terminology Criteria for Adverse Events v3.0 (CTCAE). National Cancer Institute. 12-12-0003. 9-9-0005. Ref Type: Electronic Citation
- 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.
- 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.
- 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. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Epub 2005 Sep 19.
- 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.
- 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. Epub 2006 Mar 20.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum in: Int J Radiat Oncol Biol Phys 2000 Aug 1;48(1):313. Mohuidden M [corrected to Mohiuddin M].
- 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.
- 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.
- 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.
- 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.
- Vargas C, Martínez 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. Epub 2006 Jun 20.
- 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. Review.
- 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.
- 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
- 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. Erratum in: JAMA. 2008 Feb 27;299(8):899-900.
- UFPTI 0702-PR04
- IRB201701653
- UFJ 2008-022
Study Results
Participant Flow
Recruitment Details | University of Florida Proton Therapy Institute, between 04/2008 and 04/2010 |
---|---|
Pre-assignment Detail |
Arm/Group Title | Low Risk Proton Radiation | Intermediate Risk Proton Radiation |
---|---|---|
Arm/Group Description | 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx | 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx |
Period Title: Overall Study | ||
STARTED | 122 | 106 |
COMPLETED | 122 | 106 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Low Risk Proton Radiation | Intermediate Risk Proton Radiation | Total |
---|---|---|---|
Arm/Group Description | 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx | 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx | Total of all reporting groups |
Overall Participants | 122 | 106 | 228 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
60
49.2%
|
44
41.5%
|
104
45.6%
|
>=65 years |
62
50.8%
|
62
58.5%
|
124
54.4%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
65.3
(7.5)
|
64.1
(6.9)
|
64.7
(7.2)
|
Sex: Female, Male (Count of Participants) | |||
Female |
0
0%
|
0
0%
|
0
0%
|
Male |
122
100%
|
106
100%
|
228
100%
|
Region of Enrollment (participants) [Number] | |||
United States |
122
100%
|
106
100%
|
228
100%
|
Outcome Measures
Title | Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. |
---|---|
Description | |
Time Frame | 6 months after the end of radiation therapy |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Low Risk Proton Radiation | Intermediate Risk Proton Radiation |
---|---|---|
Arm/Group Description | 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx | 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx |
Measure Participants | 122 | 106 |
Number [Participants] |
0
0%
|
0
0%
|
Title | Disease Control |
---|---|
Description | |
Time Frame | 20 years after end of radiation |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years). | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Low Risk Proton Radiation | Intermediate Risk Proton Radiation | ||
Arm/Group Description | 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx | 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx | ||
All Cause Mortality |
||||
Low Risk Proton Radiation | Intermediate Risk Proton Radiation | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Low Risk Proton Radiation | Intermediate Risk Proton Radiation | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/122 (1.6%) | 2/106 (1.9%) | ||
Gastrointestinal disorders | ||||
Rectal hemmorhage (grade 3) | 0/122 (0%) | 0 | 1/106 (0.9%) | 1 |
Proctitis (grade 3) | 0/122 (0%) | 0 | 1/106 (0.9%) | 1 |
Renal and urinary disorders | ||||
Urinary retention (grade 3) | 1/122 (0.8%) | 1 | 0/106 (0%) | 0 |
Hematuria (grade 3) | 1/122 (0.8%) | 1 | 0/106 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Low Risk Proton Radiation | Intermediate Risk Proton Radiation | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 26/122 (21.3%) | 21/106 (19.8%) | ||
Gastrointestinal disorders | ||||
Rectal hemmorhage | 12/122 (9.8%) | 12 | 14/106 (13.2%) | 14 |
Renal and urinary disorders | ||||
Urinary Frequency/urgency | 22/122 (18%) | 22 | 11/106 (10.4%) | 11 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Randal Henderson, MD, MBA |
---|---|
Organization | University of Florida |
Phone | 904-588-1800 |
rhenderson@floridaproton.org |
- UFPTI 0702-PR04
- IRB201701653
- UFJ 2008-022