Actively Recruiting
Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-06-22
102
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of extremely hypofractionated intensity modulated stereotactic body radiotherapy (SBRT) for patients with prostate cancer who have rising prostate-specific antigen (PSA) levels after radical prostatectomy. This phase II trial aims to assess changes in patient-reported gastrointestinal and urinary symptoms over two years, comparing SBRT outcomes with historical radiation therapy data. The study also explores tumor control measures and differences between MRI-guided and CT-guided radiation methods, as well as the impact of short-term versus long-term hormonal therapy. Participants receive SBRT to the prostate bed and/or pelvic lymph nodes every other day or on consecutive days over a period of up to 14 days. Hormonal therapy may be given based on the physician's judgment. The trial compares various dosing schedules and imaging guidance techniques to understand their effects on symptoms and adverse events. During the study, patients complete questionnaires on gastrointestinal and urinary symptoms at several time points up to five years. Doctors assess adverse events and monitor disease progression using standardized criteria. Follow-up visits occur every three months during the first year and every six months thereafter, allowing close monitoring of treatment effects, side effects, and cancer control outcomes over a total of five years.
CONDITIONS
Brief Title
Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of confirmed localized adenocarcinoma of the prostate treated with radical prostatectomy
- Presence of at least one: adverse pathologic features at prostatectomy, rising PSA on two tests above 0.03 ng/mL, intermediate- or high-risk genomic score, or prostate cancer in one or more lymph nodes
- CT scan and MRI of the pelvis within 120 days prior to enrollment (MRI exceptions allowed)
- Bone scan or advanced imaging within 120 days for PSA > 1.0 ng/mL
- Age 18 years or older
- Karnofsky performance status ≥ 70 and/or ECOG ≤ 2
- Ability and willingness to sign informed consent
You will not qualify if you...
- Evidence of distant metastases (except certain lymphadenopathy per investigator discretion)
- Neuroendocrine or small cell carcinoma of the prostate
- Prior pelvic radiotherapy
- History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants undergo stereotactic body radiotherapy (SBRT) every other day or on consecutive days for up to 14 days. Hormonal therapy may be given based on physician discretion.
Up to 7 visits over 14 days
Duration - Up to 5 years
After treatment, participants are followed up every 3 months for the first year, then every 6 months for up to 5 years to monitor symptoms, adverse events, and disease progression.
Quarterly visits for 1 year, then biannual visits up to 5 years
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
B
Brian Carlton
V
Vince Basehart
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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