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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy; Drug: Hormone Therapy

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 Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Brian Carlton; Phone Number: (925)212-7215; Email: bcarlton@mednet.ucla.edu
• Study Contact Backup: Name: Vince Basehart; Phone Number: (310) 267-8954; Email: vbasehart@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA / Jonsson Comprehensive Cancer Center
      • Contact: Vince Basehart; Phone Number: (310) 267-8954; Email: vbasehart@mednet.ucla.edu
      • Contact: Brian Carlton; Phone Number: 925-212-7215; Email: bcarlton@mednet.ucla.edu
      • Principal Investigator: Amar Kishan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.	Radiation: Stereotactic Body Radiation Therapy; Undergo SBRT; Other Names: SBRT; SABR; Stereotactic Ablative Body Radiation Therapy; Drug: Hormone Therapy; Receive hormonal therapy; Other Names: Chemotherapy-Hormones/Steroids; Endocrine Therapy; Hormonal Therapy; hormone treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival		Up to 5 years
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
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
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
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
Cumulative incidence of biochemical recurrence		Up to 5 years
Distant metastasis-free survival		Up to 5 years

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: Amar Kishan, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 21-000263; NCI-2021-05447 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• 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