Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02040610
• Other study ID #: PRO 1401
• Status: Recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2025

Study information

• Verified date: April 2019
• Source: Provision Center for Proton Therapy
• Contact: Natalie E Freeman, PhD
• Phone: 8659342672
• Email: natalie.freeman[@]biomed-research.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Other known NCT identifiers

• NCT02198222

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 235
• Est. completion date: December 2025
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated Proton Therapy

Locations

Country	Name	City	State
United States	Provision Cares Proton Therapy Center Knoxville	Knoxville	Tennessee
United States	Provision Cares Proton Therapy Center Nashville	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Provision Center for Proton Therapy	Center for Biomedical Research, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Salvage Androgen Deprivation Therapy	To determine the need for salvage Androgen Deprivation Therapy for biochemical or other relapse events	Every 6 months for 5 years
Primary	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	Toxicity Assessment	To determine the incidence of acute and late Gastrointestinal and Genitourinary toxicity at 2 and 5 years.	2 years & 5 years
Secondary	Analyze Quality of Life	To assess quality of life following proton therapy (QOL EPIC) at 2 and 5 years	2 years & 5 years