Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer

NCT04399824 | Withdrawn DMC FDA Device

• 2 other identifiers: 20-000051NCI-2020-01464
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well focal radiation therapy with stereotactic body radiation therapy (SBRT) or high-dose rate (HDR) brachytherapy works in treating patients with low or intermediate-risk prostate cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HDR brachytherapy uses high doses of radiation to target these tumor cells. Giving focal radiation therapy with SBRT or HDR brachytherapy may target dominant tumor cells while sparing the reminder of the prostate or surrounding normal organs and ultimately reduce side effects while maintaining disease control.

Conditions

Prostate Adenocarcinoma; Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (3)

• Biochemical progression free survival

  Will be assessed using the Phoenix definition and obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.

  At 5 years

• Incidence of adverse events

  Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0. Will be defined as the percentage of patients who encounter adverse events and calculated to indicate the toxicity level of focal radiation therapy.

  Up to 120 months (10 years)

• Change in quality of life

  Will be assessed using Prostate-Quality of Life and Expanded Prostate Cancer Index Composite. The change of the two scores will be assessed via two-sided paired t-test.

  Baseline up to 120 months

Secondary Outcomes (5)

• Prostate-specific antigen (PSA) response

  At 3, 6, 12, and 24 months

• Clinical progression free survival

  At 5 years

• Distant metastasis free survival

  At 5 years

• Development of castration-resistant disease

  Up to 120 months (10 years)

• Overall survival

  At 5 years

Study Arms (2)

Arm I (SBRT)

EXPERIMENTAL

Patients undergo SBRT in 5 fractions over 14 days in the absence of disease progression or unacceptable toxicity.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Arm II (HDR brachytherapy)

EXPERIMENTAL

Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in the absence of disease progression or unacceptable toxicity.

Radiation: High-Dose Rate Brachytherapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

High-Dose Rate Brachytherapy RADIATION

Undergo HDR brachytherapy

Also known as: Brachytherapy, High Dose

Arm II (HDR brachytherapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (SBRT); Arm II (HDR brachytherapy)

Questionnaire Administration OTHER

Ancillary studies

Arm I (SBRT); Arm II (HDR brachytherapy)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

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

Arm I (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 diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy and with the following low/intermediate-risk features:
• cT1c - T2b
• PSA =\< 15
• \< 50% cores positive
• Gleason score (GS) =\< 7 (3+4 and 4+3 included)
• Multiparametric magnetic resonance imaging (MRI) (mp-MRI) confirmed lesion(s) with only one lobe involvement of the prostate
• Unilateral disease on systematic biopsy
• No distant or locally advanced disease on standard staging exams as indicated
• Bone scan and abdominopelvic computed tomography (CT)/MRI OR
• Prostate specific membrane antigen (PSMA) positron emission tomography (PET)
• Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment

You may not qualify if:

• Gleason score \>= 8
• Gross extracapsular extension
• Seminal vesicle invasion
• Radiographic nodal or distant metastatic disease
• Androgen deprivation therapy within 90 days of enrollment
• Lesion(s) comprising \> 40% of total prostate volume
• Lesion \< 0.5 cm from urethra
• Prior radical prostatectomy
• Prior radiotherapy to the pelvis

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Alan C Lee

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: May 22, 2020
• Study Start: April 3, 2020
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

US (1)