Clincosm LogoSign in Get a demo

Proton Boost in Prostate Cancer

Sponsor
University of Cincinnati (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03564275
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
179.5
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Proton Boost
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Matched pair analysis. Each prospective patient will be matched with two historical patients based on the inclusion, exclusion and match criteria.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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 16, 2018
Anticipated Primary Completion Date :
Apr 1, 2033
Anticipated Study Completion Date :
Apr 1, 2033

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prospective Treatment Group

Proton Boost

Radiation: Proton Boost
13-15 treatments with proton therapy given as a boost to standard of care photon therapy
No Intervention: Retrospective Comparison Group

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

Outcome Measures

Primary Outcome Measures

  1. Hematuria - Change from baseline [Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years]

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

  2. Urinary Incontinence - Change from baseline [Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years]

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

  3. Dysuria - Change from baseline [Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years]

    Presence or Absence

  4. International Prostate Symptom Score - Change from baseline [Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years]

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

  5. Rectal Bleeding - Change from baseline [Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years]

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

  6. Erectile Dysfunction - Change from baseline [Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years]

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

Secondary Outcome Measures

  1. Progression Free Survival [Monitored for 10 years after completion of radiation therapy]

    Measured by time to cancer recurrence

  2. Overall Survival [Monitored for 10 years after completion of radiation therapy]

    Measured by time to cancer-related death

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Cincinnati Cincinnati Ohio United States 45267

Sponsors and Collaborators

  • University of Cincinnati

Investigators

  • Principal Investigator: William Barrett, MD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
William Barrett, Director, University of Cincinnati Cancer Institute Medical Director, Charles M. Barrett Cancer Center Professor and Chairman, Radiation Oncology University of Cincinnati, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT03564275
Other Study ID Numbers:
  • 2017-1091
First Posted:
Jun 20, 2018
Last Update Posted:
Jul 2, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by William Barrett, Director, University of Cincinnati Cancer Institute Medical Director, Charles M. Barrett Cancer Center Professor and Chairman, Radiation Oncology University of Cincinnati, University of Cincinnati
Radiation Therapy
Proton Therapy
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jul 2, 2021