Clinical Trials /

Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy

NCT04915508

Description:

This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04915508

Trial Eligibility

Document

Title

  • Brief Title: Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy
  • Official Title: Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)

Clinical Trial IDs

  • ORG STUDY ID: 21-000263
  • SECONDARY ID: NCI-2021-05447
  • NCT ID: NCT04915508

Conditions

  • Prostate Adenocarcinoma
  • Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
  • Stage IIIC Prostate Cancer AJCC v8
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Interventions

DrugSynonymsArms
Hormone TherapyChemotherapy-Hormones/Steroids, Endocrine Therapy, Hormonal Therapy, hormone treatmentTreatment (SBRT, hormone therapy)

Purpose

This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the two-year change in patient-reported gastrointestinal (GI) symptoms based
      on the Expanded Prostate Cancer Index (EPIC) instrument following stereotactic body
      radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to
      historical control data for more prolonged radiation regimens.

      II. To determine the two-year change in patient-reported urinary (GU) symptoms based on the
      EPIC instrument following stereotactic body radiotherapy (SBRT) to the prostate bed and/or
      pelvic lymph nodes, with a comparison to historical control data for more prolonged radiation
      regimens.

      SECONDARY OBJECTIVES:

      I. To quantify patient-reported GI symptoms using the EPIC instrument at 3 months, 6 months,
      1 and 5 years.

      II. To quantify patient-reported GU symptoms using the EPIC instrument at 3 months, 6 months,
      1 and 5 years.

      III. To quantify rates and severity of acute physician scored adverse events using the Common
      Terminology Criteria for Adverse Events (CTCAE version [v.] 5.0) scale.

      IV. To quantify the five-year cumulative incidence of physician scored adverse events the
      CTCAE v4.03 scale.

      V. To quantify five-year progression-free survival. VI. To quantify 5-year cumulative
      incidence of biochemical recurrence. VII. To quantify 5-year distant metastasis-free
      survival.

      EXPLORATORY OBJECTIVES:

      I. To compare all primary and secondary endpoints between patients treated with an magnetic
      resonance imaging (MRI)-guided versus a computed tomography (CT)-guided linear accelerator.

      II. To compare primary and secondary endpoints between patients treated with short course (=<
      6 months) or long-term >= 12 months) antiandrogen therapy (ADT).

      OUTLINE:

      Patients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may
      receive hormonal therapy at the discretion of the treating physician.

      After completion of study treatment, patients are followed up every 3 months for the first
      year, and then every 6 months for up to 5 years.

Trial Arms

NameTypeDescriptionInterventions
Treatment (SBRT, hormone therapy)ExperimentalPatients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician.
  • Hormone Therapy

Eligibility Criteria

        Inclusion Criteria:

          -  History of histologically confirmed, clinical localized adenocarcinoma of the prostate
             treated with radical prostatectomy with definitive intent

          -  Presence of any ONE of the following:

               -  Adverse pathologic features at the time of prostatectomy (positive surgical
                  margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR
                  presence of tertiary Gleason grade 5 disease)

               -  Documentation of rising prostate-specific antigen on at least two consecutive
                  draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL

               -  Intermediate- or high-risk Decipher genomic classifier score

               -  Identification of prostate cancer in >= 1 lymph node at the time of prostatectomy
                  (pN+ disease)

          -  CT scan and MRI of the pelvis within 120 days prior to enrollment [note: (a) if
             patient has medical contraindication to MRI, an exemption will be granted and
             enrollment can proceed; (b) for patients with PSA < 1.0 ng/mL, the treatment planning
             CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI
             can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field
             MRI]

          -  Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for
             patients with PSA > 1.0 ng/mL

          -  Age >= 18

          -  Karnofsky performance status (KPS) >= 70 and/or Eastern Cooperative Oncology Group
             (ECOG) =< 2

          -  Ability to understand, and willingness to sign, the written informed consent

        Exclusion Criteria:

          -  Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy
             below the level of the renal arteries can be deemed loco regional per the discretion
             of the investigator

          -  Patients with neuroendocrine or small cell carcinoma of the prostate

          -  Prior pelvic radiotherapy

          -  History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain
Time Frame:Baseline up to 2 years
Safety Issue:
Description:EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

Secondary Outcome Measures

Measure:Patient-reported gastrointestinal (GI) symptoms
Time Frame:At 3 months, 6 months, 1year, and 5 years
Safety Issue:
Description:EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Measure:Patient-reported genitourinary (GU) symptoms
Time Frame:At 3 months, 6 months, 1year, and 5 years
Safety Issue:
Description:EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Measure:Incidence of acute physician scored adverse events
Time Frame:Up to 5 years
Safety Issue:
Description:Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0.
Measure:Cumulative incidence of physician scored adverse events
Time Frame:Up to 5 years
Safety Issue:
Description:Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0.
Measure:Progression-free survival
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Cumulative incidence of biochemical recurrence
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Distant metastasis-free survival
Time Frame:Up to 5 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jonsson Comprehensive Cancer Center

Last Updated

July 2, 2021