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Prostate AdenocarcinomaNCT04399824

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

A study testing High-Dose Rate Brachytherapy, Quality-of-Life Assessment and Questionnaire Administration in people with Prostate Adenocarcinoma and Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
High-Dose Rate Brachytherapy, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
3 Apr 2020to 3 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Lesion < 0.5 cm from urethra
  • Prior radical prostatectomy
  • Prior radiotherapy to the pelvis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Focal Radiation Therapy (FRaT) Trial in Patients With Low/Intermediate-Risk Prostate Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate biochemical progression free survival (bPFS) using the Phoenix definition.

II. Changes in quality of life. IIa. Prostate-Quality of Life (PR-QOL). IIb. Expanded Prostate Cancer Index Composite (EPIC).

SECONDARY OBJECTIVES:

  1. Prostate-specific antigen (PSA) response at 3, 6, 12, and 24 months. II. Clinical progression free survival. IIa. Including phoenix definition, local progression by Response Evaluation Criteria in Solid Tumors (RECIST), regional progression, distant metastasis, or death.

III. Distant metastasis free survival. IV. Development of castration-resistant disease. V. Overall survival.

OUTLINE: Patients are assigned to 1 of 2 arms.

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

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

After completion of study treatment, patients are followed up for 6 weeks, every 3 months for up to 24 months, every 6 months for up to 60 months, and then every 8-12 months until 120 months.

Being tested
High-Dose Rate Brachytherapy, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Body Radiation Therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Dose Rate BrachytherapyRadiation

    Also called Brachytherapy, High Dose

    Undergo HDR brachytherapy

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

Study groups in NCT04399824
Study groupRoleWhat they receive
Arm I (SBRT)ExperimentalPatients undergo SBRT in 5 fractions over 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy
Arm II (HDR brachytherapy)ExperimentalPatients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: High-Dose Rate Brachytherapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 5 years

  2. 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.

    Measured: Up to 120 months (10 years)

  3. 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.

    Measured: Baseline up to 120 months

Secondary outcomes (5)

  1. Prostate-specific antigen (PSA) response

    PSA response of each patient at 3, 6, 12, and 24 months will be collected and the PSA changes from baseline PSA to each time point will be evaluated via two-sided paired t-test.

    Measured: At 3, 6, 12, and 24 months

  2. Clinical progression free survival

    Measured: At 5 years

  3. Distant metastasis free survival

    Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.

    Measured: At 5 years

  4. Development of castration-resistant disease

    Defined as clinical/biochemical progression of prostate cancer with testosterone <40 ng/dl [nanograms (ng) per deciliter (dL)]

    Measured: Up to 120 months (10 years)

  5. Overall survival

    Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.

    Measured: At 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start3 Apr 2020
  3. Primary completion3 Apr 2020
  4. Study completion3 Apr 2020

Why it stopped: Study did not open

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04399824
Sponsor's protocol ID
20-000051
Other IDs
NCI-2020-01464, 20-000051
Status last verified
Nov 2020
First submitted
24 Mar 2020
Last updated
6 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing High-Dose Rate Brachytherapy, Quality-of-Life Assessment and Questionnaire Administration in people with Prostate Adenocarcinoma and Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical progression free survival (time frame: At 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04399824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.

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