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

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ClinicalTrials.gov Identifier: NCT04915508
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Drug: Hormone Therapy Radiation: Stereotactic Body Radiation Therapy Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)
Actual Study Start Date : June 23, 2021
Estimated Primary Completion Date : August 1, 2026
Estimated Study Completion Date : August 1, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (SBRT, hormone therapy)
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.
 Drug: Hormone Therapy
Receive hormonal therapy
Other Names:
  • Chemotherapy-Hormones/Steroids
  • Endocrine Therapy
  • Hormonal Therapy
  • hormone treatment

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain [ Time Frame: Baseline up to 2 years ]
    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.

  2. Change of Expanded Prostate Cancer Index (EPIC) score for the genitourinary domain [ Time Frame: Baseline up to 2 years ]
    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.


Secondary Outcome Measures :
  1. Patient-reported gastrointestinal (GI) symptoms [ Time Frame: At 3 months, 6 months, 1year, and 5 years ]
    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.

  2. Patient-reported genitourinary (GU) symptoms [ Time Frame: At 3 months, 6 months, 1year, and 5 years ]
    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.

  3. Incidence of acute physician scored adverse events [ Time Frame: Up to 5 years ]
    Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0.

  4. Cumulative incidence of physician scored adverse events [ Time Frame: Up to 5 years ]
    Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0.

  5. Progression-free survival [ Time Frame: Up to 5 years ]
  6. Cumulative incidence of biochemical recurrence [ Time Frame: Up to 5 years ]
  7. Distant metastasis-free survival [ Time Frame: Up to 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • 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
Contacts and Locations
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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): NCT04915508


Contacts
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Contact: Brian Carlton (925)212-7215 bcarlton@mednet.ucla.edu
Contact: Vince Basehart (310) 267-8954 vbasehart@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Brian Carlton    925-212-7215    bcarlton@mednet.ucla.edu   
Contact: Vince Basehart    (310) 267-8954    vbasehart@mednet.ucla.edu   
Principal Investigator: Amar Kishan, MD         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Amar Kishan UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04915508    
Other Study ID Numbers: 21-000263
NCI-2021-05447 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
 Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs