Clinical Trials /

Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

NCT03388619

Description:

Background: Sometimes prostate cancer comes back after a person s prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans. Objective: To find the shortest radiation schedule that people can tolerate without strong side effects. Eligibility: People at least 18 years old who have had a prostatectomy and will get radiation Design: Participants will be screened with: - Medical history - Physical exam - Blood and urine tests - Scan that uses a small amount of radiation to make a picture of the body - Scan that uses a magnetic field to make an image of the body - Participants will provide documents that confirm their diagnosis. - Participants may have a scan of the abdomen and pelvis. Before they start treatment, participants will have another physical exam and blood tests. Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks. Participants may provide a tissue sample from a previous procedure for research. Participants will answer questions about their general well-being and function. About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
  • Official Title: A Phase I Trials of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

Clinical Trial IDs

  • ORG STUDY ID: 180028
  • SECONDARY ID: 18-C-0028
  • NCT ID: NCT03388619

Conditions

  • Cancer Of Prostate
  • Prostate Neoplasms
  • Prostate Cancer
  • Neoplasms of Prostate
  • Prostatic Cancer

Purpose

Background: Sometimes prostate cancer comes back after a person s prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans. Objective: To find the shortest radiation schedule that people can tolerate without strong side effects. Eligibility: People at least 18 years old who have had a prostatectomy and will get radiation Design: Participants will be screened with: - Medical history - Physical exam - Blood and urine tests - Scan that uses a small amount of radiation to make a picture of the body - Scan that uses a magnetic field to make an image of the body - Participants will provide documents that confirm their diagnosis. - Participants may have a scan of the abdomen and pelvis. Before they start treatment, participants will have another physical exam and blood tests. Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks. Participants may provide a tissue sample from a previous procedure for research. Participants will answer questions about their general well-being and function. About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.

Detailed Description

      BACKGROUND:

      Prostate cancer that recurs after prostatectomy (rising PSA) with no evidence of metastatic
      disease is often treated with radiation to the entire prostate bed to a dose of 66-72 Gy over
      6-7 weeks. This treatment can provide PSA control in approximately 75% of patients, but may
      have associated genitourinary and gastrointestinal toxicity due to irradiation of the rectum,
      small bowel, and bladder. Imaging of prostate cancer has improved to the extent that
      recurrent disease is often identified in the prostate bed or in other pelvic sites. The
      current standard is to irradiate the entire prostate bed to the total dose. This trial will
      test the tolerability of accelerated treatment designed to yield a similar rate of late
      toxicity. In addition, in patients with visible tumor, it will test the feasibility of
      delivering a lower dose to the prostate bed and an integrated boost (simultaneous) to the
      visible tumor to allow a higher dose to visible tumor than can be delivered with standard
      approaches.

      OBJECTIVE:

      - Define the maximum tolerated dose (MTD) hypofractionation of image guided, focally dose
      escalated post-prostatectomy radiation.

      ELIGIBILITY:

        -  PSA recurrence after prostatectomy or indications for adjuvant radiation after
           prostatectomy.

        -  No evidence of distant metastases of prostate cancer (pelvic lymph nodes are allowed).

        -  Age greater than or equal to 18 years old

        -  ECOG performance status less than or equal to 1

      DESIGN:

      This is a Phase I trial of hypofractionated, focal dose escalation with reduced dose prostate
      bed irradiation using image and pathologic guidance. The prostate bed will be treated with
      hypofractionated radiation and areas in the prostate bed or pelvis shown to have tumor on
      biopsy or with advanced imaging studies will be treated with an integrated boost to visible
      tumor. The treatment duration will be decreased sequentially in three Dose Level groups.
      Quality of life and functional outcomes such as urine, bowel, and erectile function will be
      assessed with questionnaires. A maximum of 48 patients will be enrolled.
    

Trial Arms

NameTypeDescriptionInterventions
1/Prostate bed with integrated boostExperimentalDose to prostate bed with integrated boost
    2/Prostate bed irradiation onlyExperimentalDose to prostate bed irradiation only

      Eligibility Criteria

              -  INCLUSION CRITERIA:
      
                -  Patients must have histologically or cytologically confirmed adenocarcinoma of the
                   prostate.
      
                -  Indications for post-prostatectomy radiation exist:
      
                     -  Disease progression (detectable PSA on two measurements obtained at least one
                        month apart) or
      
                     -  indications for adjuvant radiation exist (if undetectable PSA): pathologic T3,
                        T4, N+ disease or positive margins (within 1 year of prostatectomy).
      
                -  Age greater than or equal to 18 years.
      
                -  ECOG performance status less than or equal to 1 (Karnofsky greater than or equal to
                   60)
      
                -  Ability of subject to understand and the willingness to sign a written informed
                   consent document.
      
                -  Radiation is teratogenic; thus, men must agree to use adequate contraception (hormonal
                   or barrier method of birth control; abstinence) prior to study entry, for the duration
                   of study participation and up to 120 days after the last radiation. Should a woman
                   become pregnant or suspect she is pregnant while her partner is participating in this
                   study, she should inform her treating physician immediately.
      
                -  HIV positive patients are included if CD4+ T-cell count > 200 cells/uL; on stable
                   antiretroviral therapy for > 1 year with HIV viral load <200 copies/mL, and no history
                   of opportunistic infections in > 1 year.
      
              EXCLUSION CRIETERIA:
      
                -  Patients who are receiving any other investigational agents concurrently.
      
                -  Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are
                   allowed only if within the prostate bed region).
      
                -  History of radiation that would overlap with the intended treatment to the prostate
                   bed.
      
                -  Known contraindications to radiation such as inflammatory bowel disease, active
                   systemic lupus or scleroderma, or radiation hypersensitivity syndrome (Ataxia
                   Telangiectasia or Fanconi s Anemia)
      
                -  Subjects with any coexisting medical or psychiatric condition which, in the opinion of
                   the Investigator likely to interfere with study procedures and/or results.
      
                -  Medically indicated use of known radiosensitizing drugs (such as protease inhibitors)
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Define the maximum tolerated dose (MTD)
      Time Frame:3 weeks after radiation
      Safety Issue:
      Description:Define the maximum tolerated dose (MTD) hypofractionated of image guided, focally dose escalated post-prostatectomy radiation.

      Secondary Outcome Measures

      Measure:List of adverse event frequency
      Time Frame:3 weeks after radiation
      Safety Issue:
      Description:Define the toxicity profile of image-guided, focally dose escalated prostate bed radiation in patients with a local or regional recurrence of prostate cancer after prostatectomy.
      Measure:The rate of PSA control
      Time Frame:1 and 2 years after treatment
      Safety Issue:
      Description:Kaplan-Meier survival analysis and effects of clinical variables on bPFS will be assessed by the Cox proportional hazards model
      Measure:Proportion of patients that have improvement in quality of life aftertreatment
      Time Frame:1 and 2 years after treatment
      Safety Issue:
      Description:The quality of life scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for patient-specific trajectory of quality of life scores.

      Details

      Phase:Phase 1
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:National Cancer Institute (NCI)

      Trial Keywords

      • Rising PSA
      • No evidence of metastatic disease
      • Entire Prostate Bed
      • Quality of Life
      • Irradiation

      Last Updated

      November 15, 2019