AzTrials
AzTrials

Prostate CancerEarly Phase 1NCT02691169

Integrated 18F-labelled PSMA Project

A Early Phase 1 study testing 18F-DCFPyL in people with Prostate Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

There are several new therapies available to treat men with advanced prostate cancer; however, the decision making tools needed to determine the best treatment for these patients are noticeably absent. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
18F-DCFPyL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
Apr 2016to Dec 2017
Phase
Early Phase 1
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

  • Willing and able to provide written informed consent
  • Age ≥ 18 years and male
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Subjects starting abiraterone (but naïve to enzalutamide) or starting enzalutamide (but naïve to abiraterone), within approximately 1-7 days of the baseline 18F-DCFPyL PET/CT.
  • Prior docetaxel-based chemotherapy is permitted but not required
  • Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following:
Show all 15Show fewer
  • Rising PSA over a minimum 1-week interval
  • Radiographic progression in soft tissue and/or bone
  • Ongoing androgen deprivation
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Hemoglobin ≥ 90 g/L independent of transfusion
  • Platelet count ≥100 x109/L
  • Albumin ≥ 30 g/L
  • Creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min
  • Potassium ≥ 3.5 mmol/L

Who cannot join

  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Abnormal liver functions consisting of any of the following:
  • Total Bilirubin ≥ 1.5 x ULN (except for subjects with documented Gilbert's disease)
  • AST or ALT ≥ 2.5 x ULN (for subjects with known liver metastasis, AST or ALT ≤ 5 x ULN is allowed)
  • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg)
  • Active or symptomatic viral hepatitis or chronic liver disease
Show all 16Show fewer
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
  • Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 12 months
  • Known brain metastasis
  • History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of orally administered hormonal agents.
  • Acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI CTCAE (version 4.0) grade of ≤ 1; chemotherapy-induced alopecia and grade 2 peripheral neuropathy are allowed
  • Current enrollment in an investigational drug or device study, or participation in such a study within 30 days of the 18F-DCFPyL administration
  • Condition or situation which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
  • Not willing to comply with the procedural requirements of this protocol
  • Subjects who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: Comparison of PSMA-based 18F-DCFPyL PET/CT to Conventional Imaging in the Evaluation of Subjects With Castration-Resistant Prostate Cancer

There are several new therapies available to treat men with advanced prostate cancer; however, the decision making tools needed to determine the best treatment for these patients are noticeably absent. The prostate-specific membrane antigen (PSMA) is increasingly being recognized as an important target for prostate cancer imaging and determining the most effective therapy. Accordingly, a wide variety of agents are being used to image PSMA. One of these agents is 18F-DCFPyL. In this study the investigators will image men with advanced prostate cancer using 18F-DCFPyL and a positron emission computed tomography (PET/CT) scanner. The investigators will compare the results of 18F-DCFPyL PET/CT for the detection of metastases and monitoring the effects of therapy with conventional imaging (CT, bone scan) and clinical follow-up. In this way, the investigators will evaluate the benefit of using 18F-DCFPyL PET/CT to decide what is the best treatment strategy for a man with advanced prostate cancer.

Read the detailed description

This is an exploratory single centre, non-randomized, open-label, study in male subjects with metastatic, castrate-resistant PCa (CRPC) being treated with a second-line anti-androgen therapy (enzalutamide or abiraterone). The purpose of the study is to assess if 18F-DCFPyL PET/CT: 1. Shows more sites of metastatic, castrate-resistant PCa (CRPC) compared with standard imaging (bone scan and CT) at baseline and follow-up, 2. Shows response to therapy that is associated with clinical outcome.

This study will image male subjects with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using 18F-DCFPyL PET/CT for detection of metastases and therapeutic monitoring, with correlation to standard-of-care imaging (CT and bone scan) and clinical follow-up over a 1-year time period. Subjects with CRPC and planned treatment with evidence of metastases on standard-of-care imaging (CT and/or bone scan) will undergo a baseline and mid-therapy 18F-DCFPyL PET/CT.

The study design consists of three study clinic visits (screening, baseline 18F-DCFPyL PET/CT, and 8-14 week follow-up 18F-DCFPyL PET/CT) and two follow-up safety phone calls. In addition, all subjects will be followed clinically as per local standard of care with prostate-specific antigen (PSA) blood levels and standard of care imaging for up to one year following the baseline 18F-DCFPyL administration.

Conditions
Prostate Cancer
Being tested
18F-DCFPyL
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • 18F-DCFPyLDrug

    18F-DCFPyL is a sterile diagnostic radiopharmaceutical used for PET imaging.

Study groups in NCT02691169
Study groupRoleWhat they receive
18F-DCFPyL InjectionExperimentalThe subjects will receive the 18F-DCFPyL Injection (less than or equal to 9 mCi (333 MBq)) at visits 2 and 3.
Receives: Drug: 18F-DCFPyL

What is being measured

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

  1. Number of participants with [F-18]-DCFPyL-related adverse events as assessed by CTCAE v4.0

    The safety of [F-18]-DCFPyL administration to participants will be assessed by measuring changes from baseline in vital signs (blood pressure, heart rate and oxygen saturation) on the day of injection and through documentation of any other reported adverse events for up to 3 days post-administration.

    Measured: Up to 3 days post [F-18]-DCFPyL Injection

  2. Extent of baseline disease on [F-18]-DCFPyL imaging compared to extent of baseline disease on conventional imaging in each participant as assessed by counting the total number of lesions on imaging prior to starting hormonal therapy

    The extent of baseline disease on [F-18]-DCFPyL imaging (total number of lesions) will be compared to the extent of baseline disease on conventional imaging (total number of lesions) to determine [F-18]-DCFPyL imaging sensitivity.

    Measured: At the time of initial imaging

Secondary outcomes (1)

  1. Treatment response on [F-18]-DCFPyL imaging using EORTC criteria will be compared with treatment response on clinical follow-up according to PCWG2 criteria.

    Measured: 1 year post hormonal therapy initiation

Timeline

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

  1. First posted25 Feb 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

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
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02691169
Sponsor's protocol ID
JNMP-01
Status last verified
Oct 2017
First submitted
12 Feb 2016
Last updated
9 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: The anonymized individual participant data from this study may be shared with Johns Hopkins University for the purposes of analysis and publication.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 18F-DCFPyL in people with Prostate Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

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 15 inclusion and 16 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 9 Oct 2017. 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 Canada. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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?

Number of participants with [F-18]-DCFPyL-related adverse events as assessed by CTCAE v4.0 (time frame: Up to 3 days post [F-18]-DCFPyL Injection). The study lists 2 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 NCT02691169.

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 9 Oct 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Integrated 18F-labelled PSMA Project (NCT02691169) | AzTrials