Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer

Provision Center for Proton Therapy

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Hypofractionated Proton Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02040610

PRO 1401

Details and patient eligibility

About

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.

Full description

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

Enrollment: 235 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

235 participants in 2 patient groups

Low Risk Prostate Cancer

Active Comparator group

Description:

Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

Treatment:

Radiation: Hypofractionated Proton Therapy

Intermediate Risk Prostate Cancer

Active Comparator group

Description:

Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

Treatment:

Radiation: Hypofractionated Proton Therapy