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NCT04915508

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~165 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Hormone TherapyStereotactic Body Radiation Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain
Measured over Baseline up to 2 years
+1 more outcome measured

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

Explore related trials

Prostate CarcinomaDecipher

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Amar Kishan · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domainBaseline up to 2 years

    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.

  • Change of Expanded Prostate Cancer Index (EPIC) score for the genitourinary domainBaseline up to 2 years

    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.