Prostate CancerNCT03996993
Defining Recurrent Disease With Axumin™
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by Cancer Center of Irvine at 1 site in United States.
Trial summary
This project seeks to use advanced imaging (specifically, positron emission tomography/computed tomography [PET/CT]) to detect, locate, and characterize recurrent disease in the setting of patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Casodex, Axumin and Salvage Radiation, Axumin
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Dec 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men with recurrent prostate cancer.
Who may be able to join
- General requirements:
- Karnofsky performance status of >50 (or ECOG/WHO equivalent).
- Age > 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
- History of histologically confirmed adenocarcinoma of the prostate and underwent radical prostatectomy for primary treatment with curative intent.
- Men diagnosed with recurrent/persistent prostate cancer disease following radical prostatectomy based on a detectable or rising PSA value ≥ 0.1 ng/ml.
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- Positive commercial standard of care (SOC) Axumin scan at time of restaging disease.
- Patients should not have been previously treated for biochemical recurrence (BCR) (i.e., this is the first diagnosis for BCR.
- Language proficiency in English, Spanish, Japanese, Korean, Vietnamese. Our office has translators to coherently translate the consent documents to patients.
- Inclusion criteria specific for patients on response to ADT study:
- Ability to tolerate androgen deprivation therapy (Casodex and Lupron) indefinitely.
- Been off ADT for minimum of 3 months.
- Ability to receive a possible of 4 Axumin PET/CT scans within a year.
- Inclusion criteria specific for patients on response to salvage radiotherapy study:
- Considering salvage radiotherapy.
- Ability to tolerate salvage radiation therapy for 8 weeks.
Who cannot join
- General requirements:
- Patients not capable of getting PET study due to weight, claustrophobia, allergic reaction, and/or inability to lay still for the duration of the exam.
- Women and children.
- Men currently on or seeking primary treatment (surgery or radiation) for prostate cancer.
- History of bilateral orchidectomy.
- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy. This includes focal ablation techniques (HiFu).
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- Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist).
- Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Exclusion criteria specific for patients on response to ADT study:
- Being considered for salvage radiotherapy.
- Androgen deprivation therapy (ADT) in the past 3 months.
- Exclusion criteria specific for patients on response to salvage radiotherapy study:
- 1. Currently on ADT or on ADT within the past 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kenneth Tokita
Irvine, California, 92619
Kenneth M Tokita, MD, 949-417-1100, kmtokita@ccoi.org
About this study
Official title: Diagnosing and Monitoring Recurrent Disease in Prostate Cancer Patients Using a Positron Emission Tomography Radiotracer (Axumin™)
This project seeks to use advanced imaging (specifically, positron emission tomography/computed tomography [PET/CT]) to detect, locate, and characterize recurrent disease in the setting of patients with prostate cancer.
Read the detailed description
This protocol details the study design for patients with prostate cancer (PCa) who have failed primary treatment with radical prostatectomy, and now have rising PSA as indicated by a recent PSA blood draw value > 0.1 ng/ml. Patients fitting our inclusion criteria for the study, will receive an Axumin scan as part of their standard of care (SOC) treatment. If the SOC scan is positive, patients under this protocol will either subsequently receive hormone therapy OR salvage radiation therapy (not both concurrently). Patient response to therapy will be assessed with serial Axumin scans identifying additional lesions present at 3 months, 6 months, and 12 months (1 year) post-therapy, with the latter time point being our endpoint of the study.
The study aims are as follows:
- The investigators would like to understand the hormonal therapy response based on Axumin scans administered over a time course of 3 months, 6 months, and 12 months post-hormone therapy treatment.
- The investigators would like to understand the salvage radiotherapy response based on Axumin scan results incorporated into radiation treatment planning over a time course of 3 months, 6 months, and 12 months post-salvage radiation treatment.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Casodex, Axumin, Salvage Radiation, Axumin
- Keywords
- prostate cancer, Axumin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casodex, AxuminDrug
Also called Lupron
Patients will receive hormone therapy if Axumin positive area appears.
Salvage Radiation, AxuminRadiation
Patients will receive salvage radiation therapy if Axumin positive area appears.
| Study group | Role | What they receive |
|---|---|---|
| Hormone Therapy Cohort | Post-radical prostatectomy patients fitting our inclusion criteria, including rising PSA > 0.1 ng/ml, a positive SOC Axumin scan, and a patients not having received hormonal therapy for a minimum of 3 months, will receive hormonal therapy in the form of Casodex for 2 weeks, followed by Lupron indefinitely. Patients will then receive serial Axumin scans up to 1 year post-therapy. Receives: Drug: Casodex, Axumin | |
| Salvage Radiotherapy Cohort | Post-radical prostatectomy patients fitting our inclusion criteria, including rising PSA > 0.1 ng/ml, not concurrently on androgen deprivation therapy (ADT) and/or received ADT in the past 3 months, and a positive SOC Axumin scan, will receive salvage radiation therapy according to the following protocol. External beam radiation therapy will be delivered in the form of high-dose intensity modulated radiation therapy (IMRT). A total prescribed dose of 72 Gy will be delivered in 40 fractions over 8 weeks. For the first 25 fractions, the clinical target volume (CTV) is defined as the residual prostatic bed, plus internal/external iliac nodes. For the subsequent 15 fractions the CTV is defined as the residual prostatic bed plus margin. As part of SOC, the radiation fields will incorporate the Axumin positive areas into treatment planning objectives. Patients will then receive serial Axumin scans up to 1 year post-therapy. Receives: Radiation: Salvage Radiation, Axumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of baseline Axumin uptake
Utilizing standard uptake values (SUV) from the tumor origin, serial Axumin SUV values will be calculated as a percentage of the baseline SUV value.
Measured: 2019-2020
Secondary outcomes (1)
PSA blood draw
Prostate specific antigen (PSA) values expressed as [ng/ml] will be serially drawn at each time of the Axumin scan to correlate with percentage of baseline SUV value.
Measured: 2019-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Center of Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996993
- Sponsor's protocol ID
- 2018/12/7
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing and Monitoring Recurrent Disease in Prostate Cancer Patients Using a Positron Emission Tomography Radiotracer (Axumin™)
- ClinicalTrials.gov ID
- NCT03996993
- Acronym / sponsor ID
- 2018/12/7
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- prostate cancer, Axumin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cancer Center of IrvineUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 25 Jun 2019 (actual)
- 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 project seeks to use advanced imaging (specifically, positron emission tomography/computed tomography [PET/CT]) to detect, locate, and characterize recurrent disease in the setting of patients with prostate cancer.
Detailed description
This protocol details the study design for patients with prostate cancer (PCa) who have failed primary treatment with radical prostatectomy, and now have rising PSA as indicated by a recent PSA blood draw value > 0.1 ng/ml. Patients fitting our inclusion criteria for the study, will receive an Axumin scan as part of their standard of care (SOC) treatment. If the SOC scan is positive, patients under this protocol will either subsequently receive hormone therapy OR salvage radiation therapy (not both concurrently). Patient response to therapy will be assessed with serial Axumin scans identifying additional lesions present at 3 months, 6 months, and 12 months (1 year) post-therapy, with the latter time point being our endpoint of the study.
The study aims are as follows:
- The investigators would like to understand the hormonal therapy response based on Axumin scans administered over a time course of 3 months, 6 months, and 12 months post-hormone therapy treatment.
- The investigators would like to understand the salvage radiotherapy response based on Axumin scan results incorporated into radiation treatment planning over a time course of 3 months, 6 months, and 12 months post-salvage radiation treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormone Therapy Cohort | – | Drug: Casodex, AxuminPost-radical prostatectomy patients fitting our inclusion criteria, including rising PSA > 0.1 ng/ml, a positive SOC Axumin scan, and a patients not having received hormonal therapy for a minimum of 3 months, will receive hormonal therapy in the form of Casodex for 2 weeks, followed by Lupron indefinitely. Patients will then receive serial Axumin scans up to 1 year post-therapy. |
| Salvage Radiotherapy Cohort | – | Radiation: Salvage Radiation, AxuminPost-radical prostatectomy patients fitting our inclusion criteria, including rising PSA > 0.1 ng/ml, not concurrently on androgen deprivation therapy (ADT) and/or received ADT in the past 3 months, and a positive SOC Axumin scan, will receive salvage radiation therapy according to the following protocol. External beam radiation therapy will be delivered in the form of high-dose intensity modulated radiation therapy (IMRT). A total prescribed dose of 72 Gy will be delivered in 40 fractions over 8 weeks. For the first 25 fractions, the clinical target volume (CTV) is defined as the residual prostatic bed, plus internal/external iliac nodes. For the subsequent 15 fractions the CTV is defined as the residual prostatic bed plus margin. As part of SOC, the radiation fields will incorporate the Axumin positive areas into treatment planning objectives. Patients will then receive serial Axumin scans up to 1 year post-therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men with recurrent prostate cancer.
Key inclusion criteria (16 listed)
- Karnofsky performance status of >50 (or ECOG/WHO equivalent).
- Age > 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
- History of histologically confirmed adenocarcinoma of the prostate and underwent radical prostatectomy for primary treatment with curative intent.
- Men diagnosed with recurrent/persistent prostate cancer disease following radical prostatectomy based on a detectable or rising PSA value ≥ 0.1 ng/ml.
Key exclusion criteria (13 listed)
- Patients not capable of getting PET study due to weight, claustrophobia, allergic reaction, and/or inability to lay still for the duration of the exam.
- Women and children.
- Men currently on or seeking primary treatment (surgery or radiation) for prostate cancer.
- History of bilateral orchidectomy.
- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy. This includes focal ablation techniques (HiFu).
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 |
|---|---|---|
| Casodex, AxuminAlso: LupronPatients will receive hormone therapy if Axumin positive area appears. | Drug | Hormone Therapy Cohort |
| Salvage Radiation, AxuminPatients will receive salvage radiation therapy if Axumin positive area appears. | Radiation | Salvage Radiotherapy Cohort |
Primary outcome
Percentage of baseline Axumin uptake
Time frame: 2019-2020
Utilizing standard uptake values (SUV) from the tumor origin, serial Axumin SUV values will be calculated as a percentage of the baseline SUV value.
1 secondary outcome
PSA blood draw
Time frame: 2019-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by Cancer Center of Irvine 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 16 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 25 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of baseline Axumin uptake (time frame: 2019-2020). 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 25 Jun 2019.