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NCT04915508Active, not recruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
165 (actual)
First submitted
1 Jun 2021
Start date
23 Jun 2021
Primary completion date
31 Dec 2026
Lead sponsor
Jonsson Comprehensive Cancer Center
NCT number
NCT04915508

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 165
  • From 23 Jun 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior pelvic radiotherapy

Other illness

  • History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UCLA / Jonsson Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.