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Radiotherapy for Oligometastatic Prostate Cancer

Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oligometastatic Prostate Cancer

Intervention: SBRT/SHRT (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Roi Dagan, MD, MS, Principal Investigator, Affiliation: University of Florida

Overall contact:
Intake Coordinator, Phone: 877-686-6009

Summary

The purpose of this phase II study is to evaluate the outcomes of patients treated with an investigational radiation regimen using stereotactic radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.

Clinical Details

Official title: Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.

Secondary outcome:

Improvement in overall survival of patients with metastatic prostate cancer.

Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer.

Quality of life in patients treated with stereotactic radiation for metastatic prostate cancer.

Detailed description: This study will serve as a component of a larger program investigating the benefits of stereotactic radiotherapy in patients with metastatic disease. This particular study will serve as a benchmark analysis. All patients will receive stereotactic radiotherapy directed at metastatic tumors. If primary prostate cancer is active and has not previously been treated with radiation therapy, conventional radiation therapy (6-8 weeks of daily treatment) may be recommended. The metastatic tumor will be treated at the same time. Hormone therapy will be recommended for all patients. Patients will be asked to complete questionnaires at regular intervals.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Patients with metastatic cancer of the prostate,

- Patients may have received prior surgery,

- Prior radiation therapy, androgen deprivation therapy (ADT), immunotherapy, bone

metastasis directed therapy, or chemotherapy for prostate cancer. Exclusion Criteria:

- End-stage heart disease,

- End-stage liver disease,

- End-stage renal disease,

- End stage pulmonary disease

- Current brain or central nervous system metastasis.

Locations and Contacts

Intake Coordinator, Phone: 877-686-6009

University of Florida Proton Therapy Institute, Jacksonville, Florida 32206, United States; Recruiting
Intake Coordinator, Phone: 877-686-6009
Roi Dagan, MD, MS, Principal Investigator
Additional Information

Related publications:

Brawley OW. Prostate cancer epidemiology in the United States. World J Urol. 2012 Apr;30(2):195-200. doi: 10.1007/s00345-012-0824-2. Epub 2012 Apr 5. Review.

Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.

Hsiao W, Moses KA, Goodman M, Jani AB, Rossi PJ, Master VA. Stage IV prostate cancer: survival differences in clinical T4, nodal and metastatic disease. J Urol. 2010 Aug;184(2):512-8. doi: 10.1016/j.juro.2010.04.010. Epub 2010 Jun 17.

Scosyrev E, Messing EM, Mohile S, Golijanin D, Wu G. Prostate cancer in the elderly: frequency of advanced disease at presentation and disease-specific mortality. Cancer. 2012 Jun 15;118(12):3062-70. doi: 10.1002/cncr.26392. Epub 2011 Oct 17.

James ND, Sydes MR, Mason MD, Clarke NW, Anderson J, Dearnaley DP, Dwyer J, Jovic G, Ritchie AW, Russell JM, Sanders K, Thalmann GN, Bertelli G, Birtle AJ, O'Sullivan JM, Protheroe A, Sheehan D, Srihari N, Parmar MK; STAMPEDE investigators. Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial. Lancet Oncol. 2012 May;13(5):549-58. doi: 10.1016/S1470-2045(12)70088-8. Epub 2012 Mar 26. Erratum in: Lancet Oncol. 2013 Jan;14(1):e5.

Widmark A, Klepp O, Solberg A, Damber JE, Angelsen A, Fransson P, Lund JA, Tasdemir I, Hoyer M, Wiklund F, Fosså SD; Scandinavian Prostate Cancer Group Study 7; Swedish Association for Urological Oncology 3. Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. Lancet. 2009 Jan 24;373(9660):301-8. doi: 10.1016/S0140-6736(08)61815-2. Epub 2008 Dec 16. Erratum in: Lancet. 2009 Apr 4;373(9670):1174.

Warde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, Gospodarowicz M, Sanders K, Kostashuk E, Swanson G, Barber J, Hiltz A, Parmar MK, Sathya J, Anderson J, Hayter C, Hetherington J, Sydes MR, Parulekar W; NCIC CTG PR.3/MRC UK PR07 investigators. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet. 2011 Dec 17;378(9809):2104-11. doi: 10.1016/S0140-6736(11)61095-7. Epub 2011 Nov 2.

Autio KA, Scher HI, Morris MJ. Therapeutic strategies for bone metastases and their clinical sequelae in prostate cancer. Curr Treat Options Oncol. 2012 Jun;13(2):174-88. doi: 10.1007/s11864-012-0190-8. Review.

Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. doi: 10.1056/NEJMoa1001294.

Saad F, Gleason DM, Murray R, Tchekmedyian S, Venner P, Lacombe L, Chin JL, Vinholes JJ, Goas JA, Chen B; Zoledronic Acid Prostate Cancer Study Group. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst. 2002 Oct 2;94(19):1458-68.

Kelly WK, Halabi S, Carducci M, George D, Mahoney JF, Stadler WM, Morris M, Kantoff P, Monk JP, Kaplan E, Vogelzang NJ, Small EJ. Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401. J Clin Oncol. 2012 May 1;30(13):1534-40. doi: 10.1200/JCO.2011.39.4767. Epub 2012 Mar 26.

Smith MR, Saad F, Coleman R, Shore N, Fizazi K, Tombal B, Miller K, Sieber P, Karsh L, Damião R, Tammela TL, Egerdie B, Van Poppel H, Chin J, Morote J, Gómez-Veiga F, Borkowski T, Ye Z, Kupic A, Dansey R, Goessl C. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet. 2012 Jan 7;379(9810):39-46. doi: 10.1016/S0140-6736(11)61226-9. Epub 2011 Nov 15.

Logothetis CJ. Treatment of prostate cancer metastases: more than semantics. Lancet. 2012 Jan 7;379(9810):4-6. doi: 10.1016/S0140-6736(11)61540-7. Epub 2011 Nov 15.

de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.

Fizazi K, Carducci M, Smith M, Damião R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011 Mar 5;377(9768):813-22. doi: 10.1016/S0140-6736(10)62344-6. Epub 2011 Feb 25.

Mottet N, Van Damme J, Loulidi S, Russel C, Leitenberger A, Wolff JM; TAP22 Investigators Group. Intermittent hormonal therapy in the treatment of metastatic prostate cancer: a randomized trial. BJU Int. 2012 Nov;110(9):1262-9. doi: 10.1111/j.1464-410X.2012.11120.x. Epub 2012 Apr 13.

de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.

Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10.

Singh D, Yi WS, Brasacchio RA, Muhs AG, Smudzin T, Williams JP, Messing E, Okunieff P. Is there a favorable subset of patients with prostate cancer who develop oligometastases? Int J Radiat Oncol Biol Phys. 2004 Jan 1;58(1):3-10.

Rana A, Chisholm GD, Khan M, Sekharjit SS, Merrick MV, Elton RA. Patterns of bone metastasis and their prognostic significance in patients with carcinoma of the prostate. Br J Urol. 1993 Dec;72(6):933-6.

Noguchi M, Kikuchi H, Ishibashi M, Noda S. Percentage of the positive area of bone metastasis is an independent predictor of disease death in advanced prostate cancer. Br J Cancer. 2003 Jan 27;88(2):195-201. Review.

Dexiang Z, Li R, Ye W, Haifu W, Yunshi Z, Qinghai Y, Shenyong Z, Bo X, Li L, Xiangou P, Haohao L, Lechi Y, Tianshu L, Jia F, Xinyu Q, Jianmin X. Outcome of patients with colorectal liver metastasis: analysis of 1,613 consecutive cases. Ann Surg Oncol. 2012 Sep;19(9):2860-8. doi: 10.1245/s10434-012-2356-9. Epub 2012 Apr 12.

Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, Sheehan J, Gerszten PC, Chang E, Gibbs I, Soltys S, Sahgal A, Deasy J, Flickinger J, Quader M, Mindea S, Yamada Y. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e597-605. doi: 10.1016/j.ijrobp.2012.03.009. Epub 2012 May 19.

Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tomé WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. Erratum in: Med Phys. 2012 Jan;39(1):563. Dosage error in article text.

Potters L, Steinberg M, Rose C, Timmerman R, Ryu S, Hevezi JM, Welsh J, Mehta M, Larson DA, Janjan NA; American Society for Therapeutic Radiology and Oncology; American College of Radiology. American Society for Therapeutic Radiology and Oncology and American College of Radiology practice guideline for the performance of stereotactic body radiation therapy. Int J Radiat Oncol Biol Phys. 2004 Nov 15;60(4):1026-32.

Potters L, Kavanagh B, Galvin JM, Hevezi JM, Janjan NA, Larson DA, Mehta MP, Ryu S, Steinberg M, Timmerman R, Welsh JS, Rosenthal SA; American Society for Therapeutic Radiology and Oncology; American College of Radiology. American Society for Therapeutic Radiology and Oncology (ASTRO) and American College of Radiology (ACR) practice guideline for the performance of stereotactic body radiation therapy. Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):326-32. doi: 10.1016/j.ijrobp.2009.09.042.

Hann DM, Jacobsen PB, Azzarello LM, Martin SC, Curran SL, Fields KK, Greenberg H, Lyman G. Measurement of fatigue in cancer patients: development and validation of the Fatigue Symptom Inventory. Qual Life Res. 1998 May;7(4):301-10.

Starting date: May 2013
Last updated: April 14, 2015

Page last updated: August 23, 2015

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