Adenocarcinoma of the ProstatePhase 2NCT01859689
Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer
A Phase 2 study testing brachytherapy, image-guided radiation therapy and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Jonsson Comprehensive Cancer Center.
Trial summary
This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer
- What is being tested?
- brachytherapy, image-guided radiation therapy 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
- No sites listed yet
- Study dates
- Mar 2012to Sep 2013
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- Unilateral prostate cancer as determined by prostate biopsy
- Less than or equal to 3 positive biopsy cores
- No biopsy core >= 50% positive for cancer
- Karnofsky performance status (KPS) >= 70
- At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA)
Show all 10Show fewer
- Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI)
- Clinical stage T1c or T2a
- PSA < 10 ng/ml
- Gleason score 3+3=6
Who cannot join
- Patients who have previously received radiation therapy to the pelvis
- Refusal to sign the informed consent
- Patients who are participating in a concurrent treatment protocol
About this study
Official title: A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine long term 5 year prostate specific cancer (PSA) biochemical control using the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.
SECONDARY OBJECTIVES:
- To assess acute and late toxicity outcomes following targeted brachytherapy according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
II. To determine changes from baseline in health-related quality of life indicators using the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score (IPSS) questionnaire.
III. To assess the potential value of multiparametric magnetic resonance imaging, including dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular tactographic imaging in predicting the development of equivocal disease (ED) following radiation treatment.
OUTLINE:
Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Being tested
- brachytherapy, image-guided radiation therapy, laboratory biomarker analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachytherapyRadiation
Also called low-LET implant therapy, radiation brachytherapy, therapy, low-LET implant
Undergo image-guided HDR brachytherapy
image-guided radiation therapyRadiation
Undergo image-guided HDR brachytherapy
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (image-guided HDR brachytherapy) | Experimental | Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days. Receives: Radiation: brachytherapy; Radiation: image-guided radiation therapy; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical PSA control using the Phoenix definition of PSA nadir + 2
Measured: 5 years
Secondary outcomes (5)
Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0
Measured: 3 months
Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0
Measured: 6 months
Changes in health related quality of life (HR-QOL) as determined by EPIC scores
Measured: Up to 24 months
Changes in HR-QOL as determined by IIEF scores
Measured: Up to 24 months
Changes in HR-QOL as determined by IPSS scores
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies 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 2
- Primary purpose
- Treatment
- 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, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859689
- Sponsor's protocol ID
- 11-003235
- Other IDs
- NCI-2013-00647
- Status last verified
- Jan 2014
- First submitted
- 4 Apr 2013
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT01859689
- Acronym / sponsor ID
- 11-003235
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 May 2013 (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 phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To determine long term 5 year prostate specific cancer (PSA) biochemical control using the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.
SECONDARY OBJECTIVES:
- To assess acute and late toxicity outcomes following targeted brachytherapy according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
II. To determine changes from baseline in health-related quality of life indicators using the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score (IPSS) questionnaire.
III. To assess the potential value of multiparametric magnetic resonance imaging, including dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular tactographic imaging in predicting the development of equivocal disease (ED) following radiation treatment.
OUTLINE:
Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (image-guided HDR brachytherapy) | Experimental | Radiation: brachytherapy, Radiation: image-guided radiation therapy, Other: laboratory biomarker analysisPatients undergo 3 fractions of image-guided HDR brachytherapy over 2 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- Unilateral prostate cancer as determined by prostate biopsy
- Less than or equal to 3 positive biopsy cores
- No biopsy core >= 50% positive for cancer
- Karnofsky performance status (KPS) >= 70
Key exclusion criteria (3 listed)
- Patients who have previously received radiation therapy to the pelvis
- 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 |
|---|---|---|
| brachytherapyAlso: low-LET implant therapy, radiation brachytherapy, therapy, low-LET implantUndergo image-guided HDR brachytherapy | Radiation | Treatment (image-guided HDR brachytherapy) |
| image-guided radiation therapyUndergo image-guided HDR brachytherapy | Radiation | Treatment (image-guided HDR brachytherapy) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (image-guided HDR brachytherapy) |
Primary outcome
Biochemical PSA control using the Phoenix definition of PSA nadir + 2
Time frame: 5 years
5 secondary outcomes
Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0
Time frame: 3 months
Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0
Time frame: 6 months
Changes in health related quality of life (HR-QOL) as determined by EPIC scores
Time frame: Up to 24 months
Changes in HR-QOL as determined by IIEF scores
Time frame: Up to 24 months
Changes in HR-QOL as determined by IPSS scores
Time frame: Up to 24 months
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 27 Jul 2020.
Related trials for Adenocarcinoma of the Prostate
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
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
Jonsson Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brachytherapy, image-guided radiation therapy and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Jonsson Comprehensive Cancer Center.
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 10 inclusion and 3 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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 PSA control using the Phoenix definition of PSA nadir + 2 (time frame: 5 years). 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 27 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.