Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

NCT02830165 | Completed Results DMC

• 4 other identifiers: 15-001580NCI-2016-00188JCCCID608P50CA092131
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

Conditions

Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7; Stage II Prostate Adenocarcinoma AJCC v7; Stage III Prostate Adenocarcinoma AJCC v7

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications

  At 4 weeks post surgery

Secondary Outcomes (4)

• Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities

  Up to 1 year

• Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.

  score from baseline to twelve months

• Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.

  Mean change in I-PSS score from baseline to 12 months.

• Correlative Biomarker Analyses Using Tissue and Serial Blood Samples

  Baseline and to up to 1 year

Study Arms (1)

Treatment (SBRT)

EXPERIMENTAL

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (SBRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

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

Treatment (SBRT)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
• Patient desires and is medically fit to undergo prostatectomy
• Karnofsky performance status (KPS) \>= 70
• Patients on androgen deprivation therapy (ADT) are allowed
• For confirmation of high risk local failure status, patients will have any one of the following:
• Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study
• Pre-biopsy prostate-specific antigen (PSA) \>= 20
• Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy
• Gleason score 7 and \> 50% of biopsy cores positive for prostate cancer
• Clinical stage \>= T3 (staging by imaging acceptable)
• An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy

You may not qualify if:

• Distant metastases, based upon:
• CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and
• Bone scan or PSMA PET/CT within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration
• Patient is unable or unwilling to sign consent
• Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Nicholas Nickols, MD
• Organization: University of California at Los Angeles, David Geffin School of Medicine, Radiation Oncology

nnickols@mednet.ucla.edu

310 825-8278

Study Officials

• Nicholas Nickols, MD, PhD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 12, 2016
• Study Start: June 15, 2016
• Primary Completion: May 9, 2020
• Study Completion: May 27, 2022
• Last Updated: May 23, 2024
• Results First Posted: January 6, 2022

Record last verified: 2022-05

Locations

US (1)