Prostate Adenocarcinoma Clinical Trial
— EXCALIBUROfficial title:
Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)
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.
Status | Recruiting |
Enrollment | 102 |
Est. completion date | August 1, 2027 |
Est. primary completion date | August 1, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Jonsson Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain | 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. | Baseline up to 2 years | |
Primary | Change of Expanded Prostate Cancer Index (EPIC) score for the genitourinary domain | 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. | Baseline up to 2 years | |
Secondary | Patient-reported gastrointestinal (GI) symptoms | 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. | At 3 months, 6 months, 1year, and 5 years | |
Secondary | Patient-reported genitourinary (GU) symptoms | 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. | At 3 months, 6 months, 1year, and 5 years | |
Secondary | Incidence of acute physician scored adverse events | Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0. | Up to 5 years | |
Secondary | Cumulative incidence of physician scored adverse events | Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0. | Up to 5 years | |
Secondary | Progression-free survival | Up to 5 years | ||
Secondary | Cumulative incidence of biochemical recurrence | Up to 5 years | ||
Secondary | Distant metastasis-free survival | Up to 5 years |
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