- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811810
Proton Therapy for High Risk Prostate Cancer
April 22, 2019 updated by: Abramson Cancer Center of the University of Pennsylvania
Phase 2/3 Study of Dose-escalated External Beam Radiation Therapy
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: xrt and long term ADT
Radiation therapy (XRT) and long term androgen deprivation therapy
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|
OTHER: xrt, chemotherapy and short term ADT
radiation therapy (XRT), chemotherapy and short term ADT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Adverse Events
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 1, 2013
Primary Completion (ACTUAL)
April 1, 2014
Study Completion (ACTUAL)
April 1, 2014
Study Registration Dates
First Submitted
March 13, 2013
First Submitted That Met QC Criteria
March 14, 2013
First Posted (ESTIMATE)
March 15, 2013
Study Record Updates
Last Update Posted (ACTUAL)
April 23, 2019
Last Update Submitted That Met QC Criteria
April 22, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 22812
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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