RECRUITING

Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate Risk Prostate Cancer

Quick Facts

Study Start:2014-01

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02040610

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* • 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.

Inclusion Criteria

Exclusion 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.

* • 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.

Contacts and Locations

Study Contact

Natalie E Freeman, PhD

CONTACT

8659342672

natalie.freeman@biomed-research.com

Brenda J Whitehead, CCRP

CONTACT

8652433278

brenda.whitehead@biomed-research.com

Principal Investigator

J. Ben Wilkinson, M.D.

PRINCIPAL_INVESTIGATOR

Provision Center for Proton Therapy

Study Locations (Sites)

Provision Cares Proton Therapy Center Knoxville

Knoxville, Tennessee, 37909

United States

Provision Cares Proton Therapy Center Nashville

Nashville, Tennessee, 37067

United States

Collaborators and Investigators

Sponsor: Provision Center for Proton Therapy

J. Ben Wilkinson, M.D., PRINCIPAL_INVESTIGATOR, Provision Center for Proton Therapy

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 Registration Dates

Study Start Date2014-01

Study Completion Date2025-12

Study Record Updates

Study Start Date2014-01

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Prostate Cancer