Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity

NCT07077239 | Recruiting

• 2 other identifiers: 25-0627NCI-2025-05089
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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)

Keywords

prostatectomy

Outcome Measures

Primary Outcomes (1)

• Genitourinary Domain Score

  To determine the rate of 2x MCID changes in any genitourinary domain score of the patient-reported EPIC-26 QOL tool at any point between the start of treatment and 24-months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes.

  5 years

Secondary Outcomes (10)

• Gastrointestinal Domain Score

  5 years

• Sexual Domain Score

  5 years

• Change in IPSS Score

  5 years

• Long-Term Patient Reported GU Symptoms

  5 years

• Long-Term Patient-Reported GI Symptoms

  5 years

Study Arms (1)

Guided Stereotactic Body Radiotherapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pN0 or pN1 prostate cancer undergoing postoperative radiotherapy targeting the prostate bed +/- pelvic lymph nodes

You may qualify if:

• 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.
• \~. KPS ≥ 70 and/or ECOG \<2.
• Ability to understand, and willingness to sign, the written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Luca Valle, MD

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHRISTY PALODICHUK

CONTACT

+1 310-794-2971; cpalodichuk@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): August 1, 2035
• Study Completion (Estimated): August 1, 2036
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

US (1)