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High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

This study is currently recruiting participants.
Verified October 2016 by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655836
First Posted: August 2, 2012
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
  Purpose
The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the radiation treatment will be given over a 3 week period using stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves the delivery of very high individual doses of radiation to tumors with high precision. This allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose of this study is to determine the safety of brachytherapy when combined with hypofractionated SBRT.

Condition Intervention Phase
Prostate Cancer Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Radiation: Brachytherapy Radiation: Stereotactic Body Radiation Therapy Procedure: Quality-of-life assessment Other: Questionnaire administration Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of High Dose Rate Brachytherapy Combined With Stereotactic Body Radiation Therapy for Intermediate Risk Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):

Primary Outcome Measures:
  • Dose limiting toxicities (DLT) graded according to the National Cancer Institute, Common Toxicity Criteria (NCI, CTC), v 4.0 [ Time Frame: Up to 3 months ]
    Data analysis of phase I studies is descriptive. All estimates of dose-specific rates (e.g., response and toxicity) will be presented with corresponding confidence intervals using the exact method.


Secondary Outcome Measures:
  • Late nonhematologic toxicity profile [ Time Frame: Up to 5 years ]
  • Acute and late hematologic toxicity profile of HDR and SBRT combination [ Time Frame: Up to 5 years ]
  • Correlation of dosimetric parameters, including dose-volume factors for bladder and rectum, with acute toxicity [ Time Frame: Up to 5 years ]
  • Patient-reported outcomes, assessed by EPIC and AUA symptom score [ Time Frame: Up to 5 years ]

Estimated Enrollment: 42
Study Start Date: October 2012
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (HDR brachytherapy, SBRT)
Patients undergo HDR brachytherapy on day 0 followed by SBRT on days 15-30
Radiation: Brachytherapy
Undergo high dose rate brachytherapy
Other Names:
  • low-LET implant therapy
  • radiation brachytherapy
  • low-LET implant
  • internal radiotherapy
  • sealed source radiotherapy
  • curietherapy
  • endocurietherapy
Radiation: Stereotactic Body Radiation Therapy
Undergo stereotactic body radiation therapy
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy
Procedure: Quality-of-life assessment
Ancillary studies
Other: Questionnaire administration
Ancillary studies

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adenocarcinoma of the prostate with intermediate risk disease T2b-T2c or Gleason score 7 or prostate specific antigen (PSA) 10-20 ng/ml, without metastatic disease
  • To rule out metastatic disease, patients must have the following tests:

    • Bone scan within 60 days prior to registration
    • Computed tomography (CT) of abdomen/pelvis within 60 days prior to registration
  • Karnofsky performance status > 70
  • Age > 18
  • PSA blood test within 60 days prior to registration
  • Prostate biopsy within 180 days prior to registration
  • Within 60 days prior to registration, hematologic minimal values:

    • Absolute neutrophil count > 1,500/mm^3
    • Hemoglobin > 8.0 g/dl
    • Platelet count > 100,000/mm^3
  • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
  • No history of previous pelvic irradiation

Exclusion Criteria:

  • History of urological surgery or procedures predisposing to GU complications after radiation, i.e., anastomoses, stricture repair, etc. (will be determined by radiation oncologist)
  • History of prior pelvic irradiation
  • Documented distant metastatic disease
  • Prior radical prostatectomy or cryosurgery for prostate cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655836


Contacts
Contact: Robert Den, MD Robert.Den@jeffersonhospital.org
Contact: Radiation Oncology Clinical Research

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Robert Den, MD       Robert.Den@jeffersonhospital.org   
Contact: Radiation Oncology Clinical Research         
Sub-Investigator: Adam Dicker, MD, PhD         
Sub-Investigator: Maria Werner-Wasik, MD         
Sub-Investigator: Pramila Rani Anne, MD         
Sub-Investigator: Voichita Bar Ad, MD         
Sub-Investigator: Wenyin Shi, MD, PhD         
Sub-Investigator: Leonard Gomella, MD         
Sub-Investigator: Edouard Trabulsi, MD         
Sub-Investigator: Costas Lallas, MD         
Sub-Investigator: William Kevin Kelly, DO         
Sub-Investigator: Jean Hoffman-Censits, MD         
Sub-Investigator: Jianqing Lin, MD         
Sub-Investigator: Mark Hurwitz, MD         
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
Principal Investigator: Robert Den, MD Thomas Jefferson University
  More Information

Additional Information:
Publications:
Adkison JB, McHaffie DR, Bentzen SM, Patel RR, Khuntia D, Petereit DG, Hong TS, Tomé W, Ritter MA. Phase I trial of pelvic nodal dose escalation with hypofractionated IMRT for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):184-90. doi: 10.1016/j.ijrobp.2010.09.018. Epub 2010 Dec 14.
Al-Mamgani A, van Putten WL, Heemsbergen WD, van Leenders GJ, Slot A, Dielwart MF, Incrocci L, Lebesque JV. Update of Dutch multicenter dose-escalation trial of radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Nov 15;72(4):980-8. doi: 10.1016/j.ijrobp.2008.02.073. Epub 2008 May 19.
Boike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, Yan J, Foster R, Pistenmaa D, Perkins A, Cooley S, Timmerman R. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol. 2011 May 20;29(15):2020-6. doi: 10.1200/JCO.2010.31.4377. Epub 2011 Apr 4.
Brenner DJ, Martinez AA, Edmundson GK, Mitchell C, Thames HD, Armour EP. Direct evidence that prostate tumors show high sensitivity to fractionation (low alpha/beta ratio), similar to late-responding normal tissue. Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):6-13.
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, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87.
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.
Deutsch I, Zelefsky MJ, Zhang Z, Mo Q, Zaider M, Cohen G, Cahlon O, Yamada Y. Comparison of PSA relapse-free survival in patients treated with ultra-high-dose IMRT versus combination HDR brachytherapy and IMRT. Brachytherapy. 2010 Oct-Dec;9(4):313-8. doi: 10.1016/j.brachy.2010.02.196. Epub 2010 Aug 4.
Fowler J, Chappell R, Ritter M. Is alpha/beta for prostate tumors really low? Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):1021-31.
Fowler JF, Ritter MA, Chappell RJ, Brenner DJ. What hypofractionated protocols should be tested for prostate cancer? Int J Radiat Oncol Biol Phys. 2003 Jul 15;56(4):1093-104.
Galalae RM, Kovács G, Schultze J, Loch T, Rzehak P, Wilhelm R, Bertermann H, Buschbeck B, Kohr P, Kimmig B. Long-term outcome after elective irradiation of the pelvic lymphatics and local dose escalation using high-dose-rate brachytherapy for locally advanced prostate cancer. Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):81-90.
Holmboe ES, Concato J. Treatment decisions for localized prostate cancer: asking men what's important. J Gen Intern Med. 2000 Oct;15(10):694-701.
Hoskin PJ, Motohashi K, Bownes P, Bryant L, Ostler P. High dose rate brachytherapy in combination with external beam radiotherapy in the radical treatment of prostate cancer: initial results of a randomised phase three trial. Radiother Oncol. 2007 Aug;84(2):114-20. Epub 2007 May 24.
Jabbari S, Weinberg VK, Kaprealian T, Hsu IC, Ma L, Chuang C, Descovich M, Shiao S, Shinohara K, Roach M 3rd, Gottschalk AR. Stereotactic body radiotherapy as monotherapy or post-external beam radiotherapy boost for prostate cancer: technique, early toxicity, and PSA response. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):228-34. doi: 10.1016/j.ijrobp.2010.10.026. Epub 2010 Dec 22.
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
King C. Stereotactic body radiotherapy for prostate cancer: current results of a phase II trial. Front Radiat Ther Oncol. 2011;43:428-37. doi: 10.1159/000322507. Epub 2011 May 20.
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. Epub 2007 Aug 31.
Mohler J, Bahnson RR, Boston B, Busby JE, D'Amico A, Eastham JA, Enke CA, George D, Horwitz EM, Huben RP, Kantoff P, Kawachi M, Kuettel M, Lange PH, Macvicar G, Plimack ER, Pow-Sang JM, Roach M 3rd, Rohren E, Roth BJ, Shrieve DC, Smith MR, Srinivas S, Twardowski P, Walsh PC. NCCN clinical practice guidelines in oncology: prostate cancer. J Natl Compr Canc Netw. 2010 Feb;8(2):162-200.
Morton G, Loblaw A, Cheung P, Szumacher E, Chahal M, Danjoux C, Chung HT, Deabreu A, Mamedov A, Zhang L, Sankreacha R, Vigneault E, Springer C. Is single fraction 15 Gy the preferred high dose-rate brachytherapy boost dose for prostate cancer? Radiother Oncol. 2011 Sep;100(3):463-7. doi: 10.1016/j.radonc.2011.08.022. Epub 2011 Sep 14.
Oermann EK, Slack RS, Hanscom HN, Lei S, Suy S, Park HU, Kim JS, Sherer BA, Collins BT, Satinsky AN, Harter KW, Batipps GP, Constantinople NL, Dejter SW, Maxted WC, Regan JB, Pahira JJ, McGeagh KG, Jha RC, Dawson NA, Dritschilo A, Lynch JH, Collins SP. A pilot study of intensity modulated radiation therapy with hypofractionated stereotactic body radiation therapy (SBRT) boost in the treatment of intermediate- to high-risk prostate cancer. Technol Cancer Res Treat. 2010 Oct;9(5):453-62.
Pieters BR, de Back DZ, Koning CC, Zwinderman AH. Comparison of three radiotherapy modalities on biochemical control and overall survival for the treatment of prostate cancer: a systematic review. Radiother Oncol. 2009 Nov;93(2):168-73. doi: 10.1016/j.radonc.2009.08.033. Epub 2009 Sep 11. Review.
Ritter M, Forman J, Kupelian P, Lawton C, Petereit D. Hypofractionation for prostate cancer. Cancer J. 2009 Jan-Feb;15(1):1-6. doi: 10.1097/PPO.0b013e3181976614.
Ritter MA, Forman JD, and Kupelian PA. A Phase I/II trial of increasingly hypofractionated radiation therapy for prostate cancer. International Journal of Radiation Oncology Biology Physics 75, 2009.
Vargas CE, Martinez AA, Boike TP, Spencer W, Goldstein N, Gustafson GS, Krauss DJ, Gonzalez J. High-dose irradiation for prostate cancer via a high-dose-rate brachytherapy boost: results of a phase I to II study. Int J Radiat Oncol Biol Phys. 2006 Oct 1;66(2):416-23. Epub 2006 Jul 31.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01655836     History of Changes
Other Study ID Numbers: 12D.210
2012-10 ( Other Identifier: CCRRC )
First Submitted: July 31, 2012
First Posted: August 2, 2012
Last Update Posted: October 21, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type


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