Recruiting

SBRT

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT07077239

Conditions

Prostate Cancer (CRPC)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.

Conditions

Prostate Cancer (CRPC)

Study ID

NCT07077239

Start date

Jul 17, 2025

Status verified date

Aug, 2026

Completion date

Aug 1, 2036

Anticipated

Primary completion date

Aug 1, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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:

1. 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)
2. Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
3. Intermediate- or high-risk Decipher genomic classifier score
4. 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.

\~. KPS ≥ 70 and/or 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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Guided Stereotactic Body Radiotherapy

Patient who has elected to receive SBRT following prostatectomy: eligibility determination based on PSA, pathology, and/or Decipher score

Primary outcome measure

  • Genitourinary Domain Score [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

University of California at Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Luca Valle, MD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • prostatectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-08-20.