NCT04915508

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

Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

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

Type	Name	Description
DRUG	Hormone Therapy	Receive hormonal therapy
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2021-06-23
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2021-06-07
• Last updated: 2025-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study