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Proton Boost in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03564275
Recruitment Status : Enrolling by invitation
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
William Barrett, University of Cincinnati

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
Cancer of the Prostate Radiation: Proton Boost Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : April 16, 2018
Estimated Primary Completion Date : April 2033
Estimated Study Completion Date : April 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.



Primary Outcome Measures :
  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 ]
    CTCAE Scale comparison

  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 ]
    CTCAE Scale comparison

  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 ]
    Increase in patient reported urinary 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 ]
    CTCAE Scale comparison

  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 ]
    CTCAE Scale comparison


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564275


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: William Barrett, MD University of Cincinnati

Publications:
Scales CD, Amling CL, Kane CJ, et al. Can unilateral Prostate Cancer be Reliably Predicted Based Upon Biopsy Features? J Urol. 2006; 175:373.

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     History of Changes
Other Study ID Numbers: 2017-1091
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by William Barrett, University of Cincinnati:
Radiation Therapy
Proton Therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases