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NCT Number: NCT03564275

Proton Boost in Prostate Cancer

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.

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Key information

Conditions

Cancer of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton Boost

Radiation

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

Primary outcomes

  1. Hematuria - Change from baseline

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Progression Free Survival

    Time frame: Monitored for 10 years after completion of radiation therapy

    Measured by time to cancer recurrence

  2. Overall Survival

    Time frame: Monitored for 10 years after completion of radiation therapy

    Measured by time to cancer-related death

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2033
Study completion
2033
First posted
Jun 20, 2018
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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