Recruiting

Proton Therapy

Sponsor:

Provision Center for Proton Therapy

Code:

NCT02040610

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated Proton Therapy

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT02040610

Start date

Jan, 2014

Status verified date

Apr, 2019

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

235 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Low Risk Prostate Cancer

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

active comparator: Intermediate Risk Prostate Cancer

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

Interventions

Hypofractionated Proton Therapy

Primary outcome measure

  • Time to biochemical failure [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Natalie E Freeman, PhD

8659342672natalie.freeman@biomed-research.com

Brenda J Whitehead, CCRP

8652433278brenda.whitehead@biomed-research.com

Locations

Provision Cares Proton Therapy Center Knoxville

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Natalie E Freeman, PhD

8659342672natalie.freeman@biomed-research.com

Brenda Whitehead, CCRP

8652433278wil.rivers@biomed-research.com

Principal Investigator:

J. Ben Wilkinson, M.D.

Provision Cares Proton Therapy Center Nashville

Recruiting

Nashville, Tennessee, United States, 37067

Contacts

Natalie E Freeman, PhD

865-934-2672natalie.freeman@biomed-research.com

Wil J Rivers, BS

6157164736wil.rivers@biomed-research.com

Principal Investigator:

James Gray, MD

More Information

Sponsor

Provision Center for Proton Therapy

Last update posted

Apr 5, 2019

Last verified

Apr, 2019

Keywords

  • Low Risk Prostate Cancer
  • Intermediate Risk Prostate Cancer
  • Hypofractionated
  • Image Guided Proton Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Provision Center for Proton Therapy on 2019-04-05.