Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer (PR05)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01040624
First received: December 24, 2009
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: < 15% risk of + LN
Radiation: > 15% risk of + LN
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Acute grade 3 or higher treatment-related toxicity rate. [ Time Frame: 6 months after the completion of radiation therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collect and analyze quality of life, treatment-related late morbidity, disease control, and survival outcome parameters. [ Time Frame: After radiation: every 6 months for 3 years, then annually for 20 years ] [ Designated as safety issue: Yes ]
  • Collect and analyze treatment, biologic and diagnostic information that may impact quality of life, disease control, morbidity and/or survival outcomes. [ Time Frame: After radiation: every 6 months for 3 years, then annually for 20 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: December 2009
Estimated Study Completion Date: January 2035
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HR-A
< 15% risk of + LN
Radiation: < 15% risk of + LN
Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
Experimental: HR-B
> 15% risk of + LN
Radiation: > 15% risk of + LN
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

* Adenocarcinoma of the prostate.

Exclusion Criteria:

  • 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 MI (myocardial infarction) or CHF (congestive heart failure).
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040624

Locations
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Nancy P Mendenhall, MD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
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.
Michalski JM, Bae K, Roach M et al. 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 2009.
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.
Vargas C, Fryer A, Mahajan C et al. Dose-volume comparison of proton therapy and intensity-modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys 2008;70:744-751.
Bolla M, de Reijke TM, van Tienhoven G et al. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med 2009;360:2516-2527.
Ghilezan MJ, Jaffray DA, Siewerdsen JH et al. Prostate gland motion assessed with cine-magnetic resonance imaging (cine-MRI). Int J Radiat Oncol Biol Phys 2005;62:406-417.
Litzenberg D, Dawson LA, Sandler H et al. Daily prostate targeting using implanted radiopaque markers. Int J Radiat Oncol Biol Phys 2002;52:699-703.
Litzenberg DW, Balter JM, Hadley SW et al. Influence of intrafraction motion on margins for prostate radiotherapy. Int J Radiat Oncol Biol Phys 2006;65:548-553.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01040624     History of Changes
Other Study ID Numbers: UFPTI 0703 - PR05
Study First Received: December 24, 2009
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Prostate Cancer, Proton Radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgens
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014