This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Proton Therapy for High Risk Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01811810
First received: March 13, 2013
Last updated: December 14, 2015
Last verified: December 2015
  Purpose
The most common treatment for men with high risk prostate cancer is radiation therapy (XRT) followed by long term androgen deprivation therapy (ADT). Long-term AD is toxic, with substantial metabolic, physical, mental and sexual side-effects. In this study, the investigators propose a treatment strategy to optimize the control of high risk prostate cancer by using dose-escalated external beam radiation (proton therapy or IMRT) concurrent with docetaxel and adjuvant short-course AD. The investigators hypothesize that this approach will be superior to the current standard of care and obviate the need for long term AD. In this study, subjects will be randomized to either XRT with long term ADT or XRT and chemotherapy and short term ADT.

Condition Intervention Phase
Prostate Cancer Radiation: Radiation therapy (XRT) Other: Androgen Deprivation Therapy (ADT) Other: Chemotherapy Phase 2 Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase 2/3 Study of Dose-escalated External Beam Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 5 years ]

Estimated Enrollment: 120
Study Start Date: March 2013
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
xrt and long term ADT
Radiation therapy (XRT) and long term androgen deprivation therapy
Radiation: Radiation therapy (XRT) Other: Androgen Deprivation Therapy (ADT)
xrt, chemotherapy and short term ADT
radiation therapy (XRT), chemotherapy and short term ADT
Radiation: Radiation therapy (XRT) Other: Androgen Deprivation Therapy (ADT) Other: Chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma (within 365 days of randomization).
  • High-risk for recurrence as determined by evidence of at least one of the following: Gleason Score 8-10 PSA 20 T stage T3
  • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-10. 6 cores are strongly recommended.
  • Clinical stages T1a- T3 N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.-appendix III).
  • PSA values 50 ng/ml within 90 days prior to randomization. Must be completed prior to biopsy or at least 21 days after prostate biopsy.
  • Absolute Neutrophil Count (ANC) 1,800 cells/mm³ within 90 days prior to randomization.
  • Platelets 100,000 cells/mm³ within 90 days prior to randomization.
  • Hemoglobin 10 g/dl within 90 days prior to randomization. 3.1.9 ALT, AST, and total bilirubin within 1.5 X institutional upper normal limits within 90 days prior to randomization.
  • ECOG status 0-1 (appendix II) documented within 90 days of randomization.
  • Patient must sign study specific informed consent prior to randomization. Note: consent for legally authorized representative is not permitted.
  • Completed all requirements listed in section 4.0 within the specified time frames.
  • Able to start treatment within 56 days of randomization.
  • At least 18 years old and less than or equal to 75 years of age.
  • Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.
  • Medical oncology consultation prior to randomization and medically approved for chemotherapy treatment per protocol.

Exclusion Criteria:

  • Evidence of distant metastasis.
  • Pelvic lymph nodes 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
  • Prior prostate cancer surgery including but not limited to prostatectomy, hyperthermia and cryosurgery.
  • Prior pelvic radiation for their prostate cancer.
  • Prior androgen suppression.
  • Severe, active co-morbidity, defined as follows:
  • Active rectal diverticulitis, Crohns disease affecting the rectum or ulcerative colitis. (Non-active diverticulitis and Crohns disease not affecting the rectum are allowed).
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
  • Myocardial infarction within the last 6 months.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • Prior allergic reaction to the drugs involved in this protocol.
  • Existing peripheral neuropathy grade 2.
  • Prior systemic chemotherapy for prostate cancer.
  • History of proximal urethral stricture requiring dilatation.
  • Major medical, addictive or psychiatric illness which in the investigators opinion,will prevent the consent process, completion of the treatment and/or interfere with follow-up.
  • Evidence of any other cancer within the past 5 years and 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed.)
  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: NCT01811810

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: John Christodouleas, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01811810     History of Changes
Other Study ID Numbers: UPCC 22812
Study First Received: March 13, 2013
Last Updated: December 14, 2015

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Men under the age of 75 with histologically confirmed high risk

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017