Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer

NCT01040624 | Completed Results DMC

• 2 other identifiers: UFPTI 0703 - PR05IRB201702459
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Proton Radiation

Outcome Measures

Primary Outcomes (1)

• Acute Grade 3 or Higher Treatment-related Toxicity Rate.

  Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.

  6 months after the completion of radiation therapy

Secondary Outcomes (2)

• Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.

  After radiation: every 6 months for 3 years, then annually for 20 years

• Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.

  After radiation: every 6 months for 3 years, then annually for 20 years

Study Arms (2)

High-risk arm A (HR-A)

EXPERIMENTAL

\< 15% risk of + lymph nodes (LN)

Radiation: < 15% risk of + LN

HR-B

EXPERIMENTAL

\> 15% risk of + LN

Radiation: > 15% risk of + LN

Interventions

> 15% risk of + LN RADIATION

Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

HR-B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* Adenocarcinoma of the prostate.

You may not qualify if:

• Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.
• Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)
• History of hip replacement.
• Prior intrapelvic surgery. This includes the following:
• Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding
• Transabdominal pelvic surgery
• Bladder surgery
• Prior myocardial infarction (MI) or congestive heart failure (CHF).
• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (53)

• American Joint Committee on Cancer. AJCC Cancer Staging Handbook, 6th ed. New York: Springer Verlag; 2002.

  BACKGROUND

• Mendenhall NP, Li X, Morris CG, Keole S, Mendenhall WM, Nichols RC, Vargas C, Henderson RH, Early GI and GU toxicity in 3 prospective proton therapy trials for prostate cancer. Presented at the American Society of Therapeutic Radiation Oncologists. Chicago, 2009.

  BACKGROUND

• Aizer AA, Yu JB, McKeon AM, Decker RH, Colberg JW, Peschel RE. Whole pelvic radiotherapy versus prostate only radiotherapy in the management of locally advanced or aggressive prostate adenocarcinoma. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1344-9. doi: 10.1016/j.ijrobp.2008.12.082. Epub 2009 May 21.

  PMID: 19464821 BACKGROUND

• Michalski JM, Bae K, Roach M, Markoe AM, Sandler HM, Ryu J, Parliament MB, Straube W, Valicenti RK, Cox JD. Long-term toxicity following 3D conformal radiation therapy for prostate cancer from the RTOG 9406 phase I/II dose escalation study. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):14-22. doi: 10.1016/j.ijrobp.2009.01.062.

  PMID: 19577865 BACKGROUND

• Zelefsky MJ, Levin EJ, Hunt M, Yamada Y, Shippy AM, Jackson A, Amols HI. Incidence of late rectal and urinary toxicities after three-dimensional conformal radiotherapy and intensity-modulated radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1124-9. doi: 10.1016/j.ijrobp.2007.11.044.

  PMID: 18313526 BACKGROUND

• Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.

  PMID: 33532112 BACKGROUND

• 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: 9749478 BACKGROUND

• Cox JD, Kian AK. Mosby Radiation Oncology: Rationale, Technique, Results, 8th ed.C.V. Mosby; 2002.

  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: 15145151 BACKGROUND

• 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: 16029788 BACKGROUND

• 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: 10837943 BACKGROUND

• Anaya-Saavedra G, Ramirez-Amador V, Irigoyen-Camacho ME, Garcia-Cuellar CM, Guido-Jimenez M, Mendez-Martinez R, Garcia-Carranca A. High association of human papillomavirus infection with oral cancer: a case-control study. Arch Med Res. 2008 Feb;39(2):189-97. doi: 10.1016/j.arcmed.2007.08.003. Epub 2007 Nov 8.

  PMID: 18164962 BACKGROUND

• Partin AW, Mangold LA, Lamm DM, Walsh PC, Epstein JI, Pearson JD. Contemporary update of prostate cancer staging nomograms (Partin Tables) for the new millennium. Urology. 2001 Dec;58(6):843-8. doi: 10.1016/s0090-4295(01)01441-8.

  PMID: 11744442 BACKGROUND

• Makarov DV, Trock BJ, Humphreys EB, Mangold LA, Walsh PC, Epstein JI, Partin AW. Updated nomogram to predict pathologic stage of prostate cancer given prostate-specific antigen level, clinical stage, and biopsy Gleason score (Partin tables) based on cases from 2000 to 2005. Urology. 2007 Jun;69(6):1095-101. doi: 10.1016/j.urology.2007.03.042.

  PMID: 17572194 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: 11743286 BACKGROUND

• 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: 11792912 BACKGROUND

• 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: 10920135 BACKGROUND

• 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: 15817332 BACKGROUND

• Pickles T, Keyes M, Morris WJ. Brachytherapy or conformal external radiotherapy for prostate cancer: a single-institution matched-pair analysis. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):43-9. doi: 10.1016/j.ijrobp.2009.01.081.

  PMID: 19570619 BACKGROUND

• Roach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11. doi: 10.1200/JCO.2003.05.004.

  PMID: 12743142 BACKGROUND

• Lawton CA, DeSilvio M, Roach M 3rd, Uhl V, Kirsch R, Seider M, Rotman M, Jones C, Asbell S, Valicenti R, Hahn S, Thomas CR Jr. An update of the phase III trial comparing whole pelvic to prostate only radiotherapy and neoadjuvant to adjuvant total androgen suppression: updated analysis of RTOG 94-13, with emphasis on unexpected hormone/radiation interactions. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):646-55. doi: 10.1016/j.ijrobp.2007.04.003. Epub 2007 May 24.

  PMID: 17531401 BACKGROUND

• Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, Pabot du Chatelard PM, Bernier V, Voirin N, Perol D, Carrie C. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007 Dec 1;25(34):5366-73. doi: 10.1200/JCO.2006.10.5171.

  PMID: 18048817 BACKGROUND

• 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: 16160131 BACKGROUND

• 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: 15718316 BACKGROUND

• 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: 15685244 BACKGROUND

• 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: 7721636 BACKGROUND

• Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.

  PMID: 17765406 BACKGROUND

• Pollack A, Hanlon AL, Horwitz EM, Feigenberg SJ, Uzzo RG, Hanks GE. Prostate cancer radiotherapy dose response: an update of the fox chase experience. J Urol. 2004 Mar;171(3):1132-6. doi: 10.1097/01.ju.0000111844.95024.74.

  PMID: 14767286 BACKGROUND

• Fuks Z, Leibel SA, Wallner KE, Begg CB, Fair WR, Anderson LL, Hilaris BS, Whitmore WF. The effect of local control on metastatic dissemination in carcinoma of the prostate: long-term results in patients treated with 125I implantation. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):537-47. doi: 10.1016/0360-3016(91)90668-t.

  PMID: 1869452 BACKGROUND

• Vargas C, Martinez A, Boike TP, Edmundson G, Gustafson G, Krauss D. Long Term Survival Benefit of a Prospective Dose Escalation Trial Using High Dose Rate (HDR) Brachytherapy Boost. [Abstr.] Int J Radiat Oncol Biol Phys 2005;63:S37-S38.

  BACKGROUND

• Vargas C, Fryer A, Mahajan C, Indelicato D, Horne D, Chellini A, McKenzie C, Lawlor P, Henderson R, Li Z, Lin L, Olivier K, Keole S. Dose-volume comparison of proton therapy and intensity-modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):744-51. doi: 10.1016/j.ijrobp.2007.07.2335. Epub 2007 Sep 27.

  PMID: 17904306 BACKGROUND

• Zietman AL. Correction: Inaccurate analysis and results in a study of radiation therapy in adenocarcinoma of the prostate. JAMA. 2008 Feb 27;299(8):898-9. doi: 10.1001/jama.299.8.898-c. No abstract available.

  PMID: 18314431 BACKGROUND

• Karakiewicz PI, Bhojani N, Capitanio U, Reuther AM, Suardi N, Jeldres C, Pharand D, Peloquin F, Perrotte P, Shariat SF, Klein EA. External validation of the updated Partin tables in a cohort of North American men. J Urol. 2008 Sep;180(3):898-902; discussion 902-3. doi: 10.1016/j.juro.2008.05.044. Epub 2008 Jul 17.

  PMID: 18635222 BACKGROUND

• Bastide C, Brenot-Rossi I, Garcia S, Rossi D. Radioisotope guided sentinel lymph node dissection in patients with localized prostate cancer: results of the first 100 cases. Eur J Surg Oncol. 2009 Jul;35(7):751-6. doi: 10.1016/j.ejso.2008.04.007. Epub 2008 Jun 6.

  PMID: 18538526 BACKGROUND

• Winter A, Wawroschek F. Lymphadenectomy in prostate cancer. Radio-guided lymph node mapping: an adequate staging method. Front Radiat Ther Oncol. 2008;41:58-67. doi: 10.1159/000139879.

  PMID: 18544986 BACKGROUND

• Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

  PMID: 15470213 BACKGROUND

• Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. doi: 10.1056/NEJMoa041318.

  PMID: 15470214 BACKGROUND

• Chi KN, Chin JL, Winquist E, Klotz L, Saad F, Gleave ME. Multicenter phase II study of combined neoadjuvant docetaxel and hormone therapy before radical prostatectomy for patients with high risk localized prostate cancer. J Urol. 2008 Aug;180(2):565-70; discussion 570. doi: 10.1016/j.juro.2008.04.012. Epub 2008 Jun 12.

  PMID: 18554663 BACKGROUND

• Kumar P, Perrotti M, Weiss R, Todd M, Goodin S, Cummings K, DiPaola RS. Phase I trial of weekly docetaxel with concurrent three-dimensional conformal radiation therapy in the treatment of unfavorable localized adenocarcinoma of the prostate. J Clin Oncol. 2004 May 15;22(10):1909-15. doi: 10.1200/JCO.2004.02.001.

  PMID: 15143084 BACKGROUND

• Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.

  PMID: 12126818 BACKGROUND

• Crook J, Ludgate C, Malone S, Lim J, Perry G, Eapen L, Bowen J, Robertson S, Lockwood G. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):15-23. doi: 10.1016/j.ijrobp.2004.02.022.

  PMID: 15337535 BACKGROUND

• D'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7. doi: 10.1001/jama.292.7.821.

  PMID: 15315996 BACKGROUND

• Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. doi: 10.1200/JCO.2003.11.023.

  PMID: 14581419 BACKGROUND

• Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. doi: 10.1016/s0360-3016(01)01579-6.

  PMID: 11483335 BACKGROUND

• Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. doi: 10.1016/j.ijrobp.2004.08.047.

  PMID: 15817329 BACKGROUND

• D'Amico AV, Loffredo M, Renshaw AA, Loffredo B, Chen MH. Six-month androgen suppression plus radiation therapy compared with radiation therapy alone for men with prostate cancer and a rapidly increasing pretreatment prostate-specific antigen level. J Clin Oncol. 2006 Sep 1;24(25):4190-5. doi: 10.1200/JCO.2006.06.8239.

  PMID: 16943536 BACKGROUND

• Denham JW, Steigler A, Wilcox C, Lamb DS, Joseph D, Atkinson C, Matthews J, Tai KH, Spry NA, Christie D, Gleeson PS, Greer PB, D'Este C; Trans-Tasman Radiation Oncology Group 96.01 Trialists. Time to biochemical failure and prostate-specific antigen doubling time as surrogates for prostate cancer-specific mortality: evidence from the TROG 96.01 randomised controlled trial. Lancet Oncol. 2008 Nov;9(11):1058-68. doi: 10.1016/S1470-2045(08)70236-5. Epub 2008 Oct 15.

  PMID: 18929505 BACKGROUND

• Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Pierart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009 Jun 11;360(24):2516-27. doi: 10.1056/NEJMoa0810095.

  PMID: 19516032 BACKGROUND

• 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: 15890582 BACKGROUND

• 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: 10348281 BACKGROUND

• 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: 11849792 BACKGROUND

• 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: 16545919 BACKGROUND

• 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: 16111582 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Risk

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Nancy P. Mendenhall, MD
• Organization: University of Florida Health Proton Therapy Institute

rtoton@floridaproton.org

904-588-1000

Study Officials

• Nancy P Mendenhall, MD

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: December 24, 2009
• First Posted: December 29, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: April 11, 2022
• Last Updated: October 3, 2023
• Results First Posted: July 22, 2015

Record last verified: 2023-09

Locations

US (1)