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

NCT ID: NCT07077239

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-17
• Study Completion Date: 2036-08-01

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.

Detailed Description

This project is a single-arm, prospective 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. There is no pre-specified target enrollment for patients undergoing standard non-adaptive SBRT. The target enrollment of patients undergoing adaptive treatment is 200 patients. The rate of accrual is expected to be in the range of 40 patients per year.

Conditions

Prostate Cancer (CRPC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Guided Stereotactic Body Radiotherapy

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

No interventions assigned to this group

Eligibility 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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Valle, MD

Role: PRINCIPAL_INVESTIGATOR

University of California at Los Angeles

Locations

University of California at Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

CHRISTY PALODICHUK

Role: CONTACT

cpalodichuk@mednet.ucla.edu

+1 310-794-2971

Facility Contacts

CHRISTY PALODICHUK

Role: primary

cpalodichuk@mednet.ucla.edu

310-794-2971

Other Identifiers

NCI-2025-05089

Identifier Type: REGISTRY

Identifier Source: secondary_id

25-0627

Identifier Type: -

Identifier Source: org_study_id