Clinical trial NCT02040610: Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer
Official title: A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Low Risk Prostate Cancer
Intermediate Risk Prostate Cancer
Hypofractionated
Image Guided Proton Therapy
Lead sponsor: Provision Center for Proton Therapy
Sponsor class: OTHER
Collaborators: name: Center for Biomedical Research, LLC
First posted: 2014-01-20
Enrollment: 235
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Patients will receive: 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

Eligibility criteria: Inclusion Criteria:

* 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.
  * No prior radiotherapy to the pelvic area.
  * No prior prostate cancer therapy such as: prostatectomy, cryotherapy, chemotherapy or hyperthermia.
  * Platelets ≥ 100,000 cells/mm3, Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3, Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
  * Obs.: Patients with high risk factors, such as T3, Gleason 8-10 or PSA \> 20ng/mL who are not considered candidates for pelvic lymph node radiation treatment are still considered eligible for this study.

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: Time to biochemical failure
timeFrame: 5 years
Secondary outcomes:
measure: Toxicity Assessment
timeFrame: 2 years & 5 years
measure: Analyze Quality of Life
timeFrame: 2 years & 5 years
Other outcomes:
measure: Salvage Androgen Deprivation Therapy
timeFrame: Every 6 months for 5 years
Locations:
city: Knoxville
country: United States
facility: Provision Cares Proton Therapy Center Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Provision Cares Proton Therapy Center Nashville
state: Tennessee
Study officials:
affiliation: Provision Center for Proton Therapy
name: J. Ben Wilkinson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: