Stage III Prostate AdenocarcinomaNCT02597894
Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy
A study testing Biopsy of Prostate and Laboratory Biomarker Analysis in people with Stage III Prostate Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies targeted biopsies in determining response in patients with prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage III Prostate Adenocarcinoma
- What is being tested?
- Biopsy of Prostate and Laboratory Biomarker Analysis
- 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
- 1 Mar 2018to 1 Mar 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 primary adenocarcinoma of the prostate
- National Comprehensive Cancer Network (NCCN) high risk disease (cT3 or Gleason score 8-10 or prostate specific antigen [PSA] > 20)
- Not currently on ADT
- Magnetic resonance imaging (MRI) or transrectal doppler ultrasound demonstrating at least one target lesion
- Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) = 2
- Understands the trial and procedure and is willing and able to sign the informed consent form
Who cannot join
- Patient is unable to receive high dose rate prostate brachytherapy
- Patient is unable to have a MRI or transrectal ultrasound
- Refusal to sign the informed consent
- Patients who are participating in a concurrent treatment protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy
This pilot clinical trial studies targeted biopsies in determining response in patients with prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor). Studying tumor tissue obtained before and after treatment may help doctors understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is repaired after it is damaged and to see if there are differences in the prostate tissue prior to and after starting androgen deprivation therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- Demonstrate feasibility of obtaining adequate tumor tissue from an intra-prostatic index lesion prior to the start of androgen deprivation therapy (ADT) and again at the time of high-dose-rate (HDR) brachytherapy.
SECONDARY OBJECTIVES:
- Use immunohistochemistry to stain cells pre-ADT and post 2 months of ADT for markers of non-homologous end joining and DNA double strand breaks using the following markers: Ku70, Ku80, DNA-dependent protein kinase catalytic subunits (PKCs), gamma-histone family, member X (H2AX).
OUTLINE:
Patients undergo biopsy at baseline before start of ADT and during brachytherapy.
- Conditions
- Stage III Prostate Adenocarcinoma
- Being tested
- Biopsy of Prostate, Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of ProstateProcedure or surgery
Also called Prostate Biopsy, Prostatic Biopsy
Undergo biopsy
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Prostate biopsy | Other | Patients undergo two biopsies, the first at baseline before start of ADT and the second two months later during brachytherapy. Receives: Procedure: Biopsy of Prostate; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in DNA damage repair pathways
The prostate biopsy sample at baseline and at the time of brachytherapy (approximately two months later) will be examined to determine if prostate cancer is in the core and if at least 20% of the core has prostate cancer in it.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Why it stopped: P. I. left the Institution. Study never opened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Kamrava, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597894
- Sponsor's protocol ID
- 15-000360
- Other IDs
- NCI-2015-01737, JCCCID562, 15-000360
- Status last verified
- Apr 2017
- First submitted
- 2 Nov 2015
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy
- ClinicalTrials.gov ID
- NCT02597894
- Acronym / sponsor ID
- 15-000360
- Conditions
- Stage III Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: P. I. left the Institution. Study never opened
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies targeted biopsies in determining response in patients with prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor). Studying tumor tissue obtained before and after treatment may help doctors understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is repaired after it is damaged and to see if there are differences in the prostate tissue prior to and after starting androgen deprivation therapy.
Detailed description
PRIMARY OBJECTIVES:
- Demonstrate feasibility of obtaining adequate tumor tissue from an intra-prostatic index lesion prior to the start of androgen deprivation therapy (ADT) and again at the time of high-dose-rate (HDR) brachytherapy.
SECONDARY OBJECTIVES:
- Use immunohistochemistry to stain cells pre-ADT and post 2 months of ADT for markers of non-homologous end joining and DNA double strand breaks using the following markers: Ku70, Ku80, DNA-dependent protein kinase catalytic subunits (PKCs), gamma-histone family, member X (H2AX).
OUTLINE:
Patients undergo biopsy at baseline before start of ADT and during brachytherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate biopsy | Other | Procedure: Biopsy of Prostate, Other: Laboratory Biomarker AnalysisPatients undergo two biopsies, the first at baseline before start of ADT and the second two months later during brachytherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed primary adenocarcinoma of the prostate
- National Comprehensive Cancer Network (NCCN) high risk disease (cT3 or Gleason score 8-10 or prostate specific antigen [PSA] > 20)
- Not currently on ADT
- Magnetic resonance imaging (MRI) or transrectal doppler ultrasound demonstrating at least one target lesion
- Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) = 2
Key exclusion criteria (4 listed)
- Patient is unable to receive high dose rate prostate brachytherapy
- Patient is unable to have a MRI or transrectal ultrasound
- Refusal to sign the informed consent
- Patients who are participating in a concurrent treatment protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy of ProstateAlso: Prostate Biopsy, Prostatic BiopsyUndergo biopsy | Procedure or surgery | Prostate biopsy |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Prostate biopsy |
Primary outcome
Changes in DNA damage repair pathways
Time frame: Two months
The prostate biopsy sample at baseline and at the time of brachytherapy (approximately two months later) will be examined to determine if prostate cancer is in the core and if at least 20% of the core has prostate cancer in it.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Kamrava principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy of Prostate and Laboratory Biomarker Analysis in people with Stage III Prostate Adenocarcinoma, 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 6 inclusion and 4 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 24 Jul 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?
Changes in DNA damage repair pathways (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2020.