Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

NCT03541850 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 17-001064NCI-2017-02032
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

Conditions

PSA Level Greater Than 0.03; PSA Progression; Stage I Prostate Adenocarcinoma AJCC (American Joint Committee on Cancer ) v7; Stage II Prostate Adenocarcinoma AJCC v7; Stage III Prostate Adenocarcinoma AJCC v7

Outcome Measures

Primary Outcomes (4)

• Biochemical recurrence-free survival (BCRFS)

  Defined as serum prostate-specific antigen (PSA) rising from the post-treatment nadir to a level of 0.4 ng/mL or more with a confirmatory second test, initiation of salvage androgen deprivation therapy, or continued rise in PSA after stereotactic body radiation therapy (SBRT). The Kaplan-Meier product-limit estimate of the BCRFS will be estimated and presented graphically. One sample log-rank test will be used to test difference in BCRFS between intervention and historical control. The median BCRFS time will be calculated with 95% confidence interval. Summaries of the number and percentage of patients experiencing a biochemical recurrence will be provided.

  Up to 5 years

• Physician-scored toxicity

  Represented by the rates of acute (early, within 90 days of SBRT) and late (90 or more days after SBRT) genitourinary and gastrointestinal toxicity based on the Common Terminology Criteria for Adverse Events version 4.03. Adverse Events (AEs) and serious adverse events (SAEs) will be listed individually by patient.

  Up to 5 years

• Patient-reported toxicity outcomes EPIC-26

  Patient-reported toxicity outcomes represented by changes in the urinary incontinence, urinary obstruction, bowel, sexual function, and hormone/vitality domains on the Expanded Prostate Cancer Index-26 (EPIC-26) quality of life instrument (scored from 0-100 points for each domain, higher scores reflect worse symptom/bother severity.)

  Up to 5 years

• Patient-reported toxicity outcomes IPSS

  Patient-reported toxicity outcomes represented by changes in International Prostate Symptom Scores (IPSS) (scored from 0-35 points, higher scores reflect worse symptom/bother severity.).

  Up to 5 years

Secondary Outcomes (1)

• Proportion of stereotactic body radiation therapy (SBRT) fractions for which on-line adaptive radiotherapy was utilized in the subset of patient treated with magnetic resonance imaging (MRI)-guided radiotherapy

  Up to 5 years

Other Outcomes (4)

• Physician-scored Toxicity profiles patients treated utilizing a linear accelerator

  Up to 5 years

• Patient-reported toxicity outcomes; patients treated utilizing a linear accelerator

  Up to 5 years

• Physician-scored toxicity profiles patients treated utilizing the magnetic resonance imaging (MRI)-guided device

  Up to 5 years

Study Arms (1)

Treatment (SBRT, ADT)

EXPERIMENTAL

Patients undergo SBRT QOD for 14 days. Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.

Drug: Antiandrogen Therapy; Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy

Interventions

Antiandrogen Therapy DRUG

Receive luteinizing hormone-releasing hormone agonist or gonadotropin-releasing hormone antagonist, and oral anti-androgen

Also known as: ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy

Treatment (SBRT, ADT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (SBRT, ADT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (SBRT, ADT)

Eligibility Criteria

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

You may qualify if:

• History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
• Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
• Computed tomography (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)
• Bone scan within 120 days prior to enrollment; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis, and advanced imaging (e.g., 18NaF positron emission tomography \[PET\]/CT) is strongly recommended
• Karnofsky performance score (KPS) \>= 70
• Ability to understand, and willingness to sign, the written informed consent

You may not qualify if:

• Patients with any evidence of distant metastases
• Patients with pathologically-confirmed N1 prostate cancer
• Patients with neuroendocrine or small cell carcinoma of the prostate
• Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate
• Prior pelvic radiotherapy
• History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Viewray Inc.: collaborator

Study Sites (2)

USC Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• Nikitas J, Ballas LK, Romero T, Lynch C, Ma TM, Valle LF, Sachdeva A, Chong N, Basehart V, Franco A, Reiter R, Saigal C, Chamie K, Litwin MS, Donin NM, Rettig M, Nickols NG, Cao M, Liauw SL, Steinberg ML, Kishan AU. Patient-Reported Outcomes With Stereotactic Intensity Modulated Radiotherapy After Radical Prostatectomy: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Jul 1;11(7):726-734. doi: 10.1001/jamaoncol.2025.1059.

  PMID: 40372727 DERIVED

• Nikitas J, Smith LM, Gao Y, Ma TM, Sachdeva A, Yoon SM, Jiang T, Low DA, Ballas LK, Steinberg ML, Cao M, Kishan AU. The role of adaptive planning in margin-reduced, MRI-guided stereotactic body radiotherapy to the prostate bed following radical prostatectomy: Post-hoc analysis of a phase II clinical trial. Radiother Oncol. 2023 Jun;183:109631. doi: 10.1016/j.radonc.2023.109631. Epub 2023 Mar 18.

  PMID: 36934894 DERIVED

MeSH Terms

Interventions

Androgen Antagonists; Radiosurgery

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Amar Kishan, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 31, 2018
• Study Start: January 29, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (2)