Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer
A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate Risk Prostate Cancer
1 other identifier
interventional
235
1 country
2
Brief Summary
This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Jan 2014
Longer than P75 for not_applicable prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 16, 2014
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 5, 2019
April 1, 2019
5.9 years
January 16, 2014
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to biochemical failure
To determine the freedom from biochemical failure survival outcomes (FFBF) and compare to historical FFBF results achieved following standard fractionation proton therapy
5 years
Secondary Outcomes (2)
Toxicity Assessment
2 years & 5 years
Analyze Quality of Life
2 years & 5 years
Other Outcomes (1)
Salvage Androgen Deprivation Therapy
Every 6 months for 5 years
Study Arms (2)
Low Risk Prostate Cancer
ACTIVE COMPARATORHypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
Intermediate Risk Prostate Cancer
ACTIVE COMPARATORHypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Pathological (histologically) proven diagnosis of prostatic adenocarcinoma within 365 days (1 year) prior to study registration.
- History and physical exam with digital rectal exam of the prostate to establish clinical staging
- Clinical stage T1-T2c (AJCC 7th edition) within 90 days of registration.
- Prostate specific antigen (PSA) \< 20 ng/mL within 90 days prior to registration.
- Gleason Score \< 7.
- Eastern Cooperative Oncology Group(ECOG) Performance status 0-1.
- Clinically negative lymph nodes evaluated by imaging (pelvic +/- abdominal CT or MRI scan).
- Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are ≤ 1.5 cm in diameter; any node larger than this on imaging will require negative biopsy for eligibility, unless the node is know to be enlarged from prior scans and considered stable, per discretion of the treating physician.
- Patients must be 18 years of age or older.
- Patient must be able to provide study-specific informed consent prior to study entry.
- Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire.
- No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
- Bone scan is not required for patients enrolled with a single intermediate risk factor only, but this scan may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors will require a negative bone scan for eligibility.
- Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
- Patient is able to start proton therapy or neo-adjuvant hormonal therapy, when recommended, within 12 weeks of registration.
- +4 more criteria
You may not qualify if:
- Prior radiotherapy to the pelvic area.
- Prior prostate cancer therapy such as: prostatectomy, cryotherapy, or hyperthermia.
- Prior systemic therapy (chemotherapy) for prostate cancer.
- Evidence of distant metastases.
- Regional lymph node involvement.
- Previous or concurrent cytotoxic chemotherapy for prostate cancer.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (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. Protocol-specific requirements may also exclude immune-compromised patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Provision Cares Proton Therapy Center Knoxville
Knoxville, Tennessee, 37909, United States
Provision Cares Proton Therapy Center Nashville
Nashville, Tennessee, 37067, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Ben Wilkinson, M.D.
Provision Center for Proton Therapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2014
First Posted
January 20, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2025
Last Updated
April 5, 2019
Record last verified: 2019-04