Advanced radiation therapy for prostate cancer with rising PSA after surgery
Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)
This study is testing a new type of focused radiation therapy for men with prostate cancer whose PSA levels are going up after surgery to see if it can reduce side effects and improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04915508 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of extremely hypofractionated intensity modulated stereotactic body radiotherapy (SBRT) in patients with prostate cancer who have rising prostate-specific antigen (PSA) levels following radical prostatectomy. The study aims to assess changes in gastrointestinal and urinary symptoms reported by patients over two years, comparing results to historical data from longer radiation regimens. The approach utilizes high-precision radiation delivery to target tumors while minimizing damage to surrounding healthy tissue, potentially leading to fewer side effects and improved patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include men with localized prostate adenocarcinoma who have undergone radical prostatectomy and exhibit rising PSA levels or specific adverse pathologic features.
Not a fit: Patients with low-risk prostate cancer or those who have not undergone radical prostatectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less harmful option for patients experiencing rising PSA levels after prostate surgery.
How similar studies have performed: Other studies have shown promising results with similar hypofractionated radiation approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Amar Kishan — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Brian Carlton
- Email: bcarlton@mednet.ucla.edu
- Phone: (925)212-7215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.