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Proton Boost in Prostate Cancer

Primary Purpose

Cancer of the Prostate

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Proton Boost

About this trial

This is an interventional treatment trial for Cancer of the Prostate focused on measuring Radiation Therapy, Proton Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

≥18 years of age
Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) <10) -OR-
Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20)
Life expectancy >10 yrs
Physically and mentally capable of signing the consent form of their own volition

Exclusion Criteria:

< 18 years of age
Diagnosis of high risk prostate cancer (T3 or higher, Gleason >7 and/or PSA >20)
Current or historical use of androgen deprivation therapy
Nodal positivity
Previous cancer excluding non-melanoma skin cancer
History of prostatectomy
History of brachytherapy for prostate cancer
Life expectancy <10 yrs
Physically or mentally incapable of signing the consent form of their own volition

Sites / Locations

University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prospective Treatment Group

Retrospective Comparison Group

Arm Description

Proton Boost

Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.

Outcomes

Primary Outcome Measures

Hematuria - Change from baseline

Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe)

Urinary Incontinence - Change from baseline

Common Terminology Criteria for Adverse Events - Urinary Incontinence Scale - 1(least severe) - 3 (most severe)

Dysuria - Change from baseline

Presence or Absence

International Prostate Symptom Score - Change from baseline

Records patient reported urinary symptoms - Scale 1-35 - 1-7 Mild symptoms, 8-19 Moderate symptoms, 20-35 Severe symptoms

Rectal Bleeding - Change from baseline

Common Terminology Criteria for Adverse Events - Rectal Hemorrhage Scale - 1(least severe) - 5 (most severe)

Erectile Dysfunction - Change from baseline

Common Terminology Criteria for Adverse Events - Erectile Dysfunction Scale - 1(least severe) - 3 (most severe)

Secondary Outcome Measures

Progression Free Survival

Measured by time to cancer recurrence

Overall Survival

Measured by time to cancer-related death

Full Information

NCT ID

NCT03564275

First Posted

May 18, 2018

Last Updated

July 1, 2021

Sponsor

University of Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT03564275

Brief Title

Proton Boost in Prostate Cancer

Official Title

Assessing the Effectiveness of Photon Therapy With a Proton Therapy Boost in the Treatment of Prostate Cancer as Compared to Photon Therapy Alone

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Enrolling by invitation

Study Start Date

April 16, 2018 (Actual)

Primary Completion Date

April 2033 (Anticipated)

Study Completion Date

April 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the Prostate

Keywords

Radiation Therapy, Proton Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Matched pair analysis. Each prospective patient will be matched with two historical patients based on the inclusion, exclusion and match criteria.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prospective Treatment Group

Arm Type

Experimental

Arm Description

Proton Boost

Arm Title

Retrospective Comparison Group

Arm Type

No Intervention

Arm Description

Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.

Intervention Type

Radiation

Intervention Name(s)

Proton Boost

Intervention Description

13-15 treatments with proton therapy given as a boost to standard of care photon therapy

Primary Outcome Measure Information:

Title

Hematuria - Change from baseline

Description

Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe)

Time Frame