External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer

This study has been terminated.
(enrollment goals not met)
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group
ClinicalTrials.gov Identifier:
NCT01603420
First received: May 18, 2012
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.


Condition Intervention Phase
Prostate Cancer
Drug: LHRH
Drug: Docetaxel
Other: Conformal RT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2/3 Study of Dose-escalated External Beam Radiation Therapy With or Without Chemotherapy for High Risk Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by Proton Collaborative Group:

Primary Outcome Measures:
  • Phase 2 - Assessment of number of Freedom from Failure events in the chemotherapy arm [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
    Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA > = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation.

  • Phase 2 - Assessment of number of Freedom from Failure event comparing chemotherapy arm to standard treatment arm [ Time Frame: at 5 years ] [ Designated as safety issue: Yes ]
    This endpoint will be examined if decision is made to not move forward with phase 3 study.

  • Phase 2 - Cumulative number of incidences of grade 3 or higher adverse events. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Assessment will be performed using CTCAE v4 criteria.

  • Phase 3 - Assessment of the number of Freedom From Failure (FFF) events comparing the chemotherapy arm to the standard treatment arm. [ Time Frame: at 5 years ] [ Designated as safety issue: Yes ]
    The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA > = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation.


Secondary Outcome Measures:
  • Assessment of number of grade 2 or higher GU and GI adverse events [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
    Assessment will be performed using CTCAE v 4 criteria.

  • Assessment of number of GI and GU adverse events [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
    Descriptive measurements of frequency will be compiled.

  • Assessment of total number of local/distant failures [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • Assessment of impotence by summation of relative scores for sexual function from the EPIC quality of life instrument. [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Assessment of total number of salvage androgen deprivation use with comparison of arms. [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Assessment of total number of survival events with comparison of group arms [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • Assessment of total number of biochemical failure events [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • Assessment of quality of life - summation of relative scores from the EPIC instrument. [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiation + 24mo LHRH
Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Drug: LHRH
Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Other Names:
  • -Androgen Suppression
  • -Androgen Deprivation
  • -Zoladex
  • -Lupron
  • -Eligard
  • -Viadur
Other: Conformal RT
1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Other Names:
  • IMRT
  • Proton Therapy
  • Particle Therapy
Experimental: Radiation + Chemo + 6mo LHRH
Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Drug: Docetaxel
Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Other Names:
  • -taxotere
  • -docetaxel
Other: Conformal RT
1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Other Names:
  • IMRT
  • Proton Therapy
  • Particle Therapy

Detailed Description:

The recommended treatment for a high risk prostate cancer consists of a combination of radiation therapy and androgen suppression for 2-3 years. Recent studies have shown a survival advantage for chemotherapy for prostate cancer. Chemotherapy has already been successfully integrated in the treatment of other cancer types and is our belief that chemotherapy will prove to be beneficial for patients with high risk prostate cancer. However, a clinical study is necessary to compare the results good or bad of chemotherapy with radiation therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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 state 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.
  • 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 deprivation.
  • Severe, active co-morbidity, defined as follows:
  • Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis. (Non-active diverticulitis and Crohn's 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 investigator's 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: NCT01603420

Locations
United States, Illinois
CDH Proton Center
Warrenville, Illinois, United States, 60555
United States, Oklahoma
Procure Proton Therapy Center
Oklahoma City, Oklahoma, United States, 73142
United States, Virginia
Hampton University Proton Therapy Institute
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Proton Collaborative Group
Investigators
Study Chair: Carlos Vargas, MD Proton Collaborative Group
  More Information

No publications provided by Proton Collaborative Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT01603420     History of Changes
Other Study ID Numbers: GU004-11
Study First Received: May 18, 2012
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Proton Collaborative Group:
prostate
cancer
radiation
proton
chemotherapy
high risk

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 28, 2014