Study Stopped
enrollment goals not met
External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer
Phase 2/3 Study of Dose-escalated External Beam Radiation Therapy With or Without Chemotherapy for High Risk Adenocarcinoma of the Prostate
1 other identifier
interventional
2
1 country
3
Brief Summary
The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
Started Jul 2012
Shorter than P25 for phase_2 prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2012
CompletedFirst Posted
Study publicly available on registry
May 22, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
August 31, 2015
CompletedMarch 14, 2016
February 1, 2016
1.8 years
May 18, 2012
July 31, 2015
February 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm
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 (Prostate Specific Antigen \[PSA\] \> = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation. This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).
No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.
Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm
This endpoint will be examined if decision is made to not move forward with phase 3 study. This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.
at 5 years
Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.
Assessment will be performed using CTCAE v4 criteria. This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).
2 years
Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.
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. This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.
at 5 years
Secondary Outcomes (8)
Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events
at 6 months
Assessment of Number of GI and GU Adverse Events
at 3 years
Assessment of Total Number of Local/Distant Failures
at time of study closure (22 months)
Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.
Up to 10 years
Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.
At study closure (22 months)
- +3 more secondary outcomes
Study Arms (2)
Radiation + 24mo luteinizing hormone-releasing hormone (LHRH)
ACTIVE COMPARATORConformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Radiation + Chemo + 6mo luteinizing hormone-releasing hormone
EXPERIMENTALConformal 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).
Interventions
Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
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).
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CDH Proton Center
Warrenville, Illinois, 60555, United States
Procure Proton Therapy Center
Oklahoma City, Oklahoma, 73142, United States
Hampton University Proton Therapy Institute
Hampton, Virginia, 23666, United States
Related Publications (1)
Guttilla A, Bortolus R, Giannarini G, Ghadjar P, Zattoni F, Gnech M, Palumbo V, Valent F, Garbeglio A, Zattoni F. Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial. Radiat Oncol. 2014 Jan 14;9:24. doi: 10.1186/1748-717X-9-24.
PMID: 24423462DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Corey Woods
- Organization
- The Proton Collaborative Group
Study Officials
- STUDY CHAIR
Carlos Vargas, MD
Proton Collaborative Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2012
First Posted
May 22, 2012
Study Start
July 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
March 14, 2016
Results First Posted
August 31, 2015
Record last verified: 2016-02