CLINICAL TRIAL

Fluciclovine F18 for Adenocarcinoma

Locally Advanced
Metastatic
Recruiting · 18+ · Male · Atlanta, GA

This study is evaluating whether a PET/CT scan using fluciclovine F18 or 68Ga-PSMA may help plan radiation treatments and enhance outcomes in patients with prostate aden

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About the trial for Adenocarcinoma

Eligible Conditions
Adenocarcinoma, Prostate · Adenocarcinoma

Treatment Groups

This trial involves 2 different treatments. Fluciclovine F18 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Computed Tomography
PROCEDURE
Positron Emission Tomography
PROCEDURE
Fluciclovine F18
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Gallium Ga68-labeled PSMA-11
RADIATION
Computed Tomography
PROCEDURE
Positron Emission Tomography
PROCEDURE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3460
Positron Emission Tomography
2019
Completed Phase 2
~2950
Fluciclovine (18F)
FDA approved

Eligibility

This trial is for male patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adenocarcinoma of the prostate, post radical-prostatectomy
Detectable prostate-specific antigen (PSA)
Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan
No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis
Willingness to undergo pelvic radiotherapy
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years after study start
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2 years after study start
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years after study start.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Fluciclovine F18 will improve 1 primary outcome and 6 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of Up to 5 years after study start.

PTV of the bladder (V65, V40)
UP TO 5 YEARS AFTER STUDY START
Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute GU or GI toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively.
UP TO 5 YEARS AFTER STUDY START
PTV of the rectum (V65, V40)
UP TO 5 YEARS AFTER STUDY START
Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute genitourinary (GU) or gastrointestinal (GI) toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively.
UP TO 5 YEARS AFTER STUDY START
Decision to offer radiotherapy
UP TO 5 YEARS AFTER STUDY START
Decision to offer radiotherapy or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
UP TO 5 YEARS AFTER STUDY START
Prostate bed clinical target volume (CTV) and planning target volume (PTV)
UP TO 5 YEARS AFTER STUDY START
Paired t-test will be used to compare the target volumes (CTV and PTV) and the planned dose delivered to surrounding bladder, rectum, and penile bulb between the initial (pre-positron emission tomography [PET]) and final (post-PET) radiation treatment plans.
UP TO 5 YEARS AFTER STUDY START
Decision to boost between the initial and final treatment decisions
UP TO 5 YEARS AFTER STUDY START
Decision to boost or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
UP TO 5 YEARS AFTER STUDY START
Decision to treat pelvic nodes
UP TO 5 YEARS AFTER STUDY START
Decision to provide treatment on pelvic nodes or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
UP TO 5 YEARS AFTER STUDY START
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Who is running the study

Principal Investigator
A. B. J.
Ashesh B Jani, Principal Investigator
Emory University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is fluciclovine f18 typically used in combination with any other treatments?

Fluciclovine H Cl has been used in combination with radiation, radical prostatectomy, and hormone therapy. Data from a recent study support the conclusion that the combination of radiation with fluciclovine H Cl would be highly effective in the treatment of prostate cancer.

Anonymous Patient Answer

Can adenocarcinoma be cured?

Adenocarcinoma can be cured only in a very rare case. It is impossible to cure it, but it can be controlled and it can be avoided in its early stages. Patients can be motivated not to develop it.

Anonymous Patient Answer

Does fluciclovine f18 improve quality of life for those with adenocarcinoma?

These data support the use of F18 in patients with locally advanced or metastatic adenocarcinoma. The small but significant increase in QOL that was seen in the treated group, relative to the control group, warrants further study.

Anonymous Patient Answer

How serious can adenocarcinoma be?

adenocarcinoma remains a very serious disease with a very poor post-operative prognosis. Despite the increased awareness and improved understanding of the disease, the use of surgery remains the gold standard treatment. The management of patients with adenocarcinoma remains problematic and it often requires referral to a tumor board outside the field of oncology.

Anonymous Patient Answer

What are common treatments for adenocarcinoma?

Treatment of adenocarcinoma varies widely, depending on many factors like surgeon experience and the availability of new treatments like definitive chemoradiotherapy and chemotherapy. Adjuvant chemotherapy is a common practice in the United States, while in the U.K. it is much less common. More than half of cancers will come down on untreated, untreated tumors.

Anonymous Patient Answer

What causes adenocarcinoma?

Adenocarcinoma involves both benign tumor-like processes as well as malignant cancerlike processes, and can be caused by any of several mechanisms. It is important to differentiate adenocarcinoma from adenoma as the two can usually be distinguished on endoscopic ultrasound imaging.

Anonymous Patient Answer

How many people get adenocarcinoma a year in the United States?

Adenocarcinoma is the second-most common cancer in American men. Each year, 1.5 million men are diagnosed with this disease. Over half (53%) of newly diagnosed cancers in the U.S. are metastatic, and 7 million people will die of the disease. Adenocarcinoma of the pancreas, colorectal, or stomach accounts for almost two-thirds (64%) of all new cases.

Anonymous Patient Answer

What is adenocarcinoma?

Adenocarcinoma is a malignant (cancerous) type of adenocarcinoma and is a form of adenocarcinoma of the colon. Adenocarcinomas are the most common form of colorectal cancer and are generally more aggressive than other types but most frequently metastatic to the lymph nodes. Symptoms of adenocarcinoma tend to occur earlier at an earlier age than other types of colorectal cancer. The development of metastatic adenocarcinoma depends to a large extent upon the stage of the disease. Metastatic adenocarcinoma may either be synchronous or metachronous.

Anonymous Patient Answer

What are the signs of adenocarcinoma?

Results from a recent clinical trial are useful when assessing breast masses, particularly in the setting of high-risk populations such as pre-menopausal women and African American women.

Anonymous Patient Answer

What are the latest developments in fluciclovine f18 for therapeutic use?

Data from a recent study confirm that fluciclovine is being effectively used as a therapeutic agent and it is a drug with a new application paradigm similar to that of flutamide for prostate cancer. Data from a recent study suggest that flucidline may be useful even in the therapeutic setting where we encounter patients with high levels of circulating testosterone.

Anonymous Patient Answer

What does fluciclovine f18 usually treat?

Fluciclovine was effective for most of our patients with elevated tracers. However, the majority (53%) of the patients needed to undergo one or more procedures. Results from a recent clinical trial indicate that fluciclovine for most of our patients does not allow the use of PET at the time of initiation of therapy.

Anonymous Patient Answer

How quickly does adenocarcinoma spread?

A significant number of patients with adenocarcinoma are known to have early metastasis. The most common time of metastasis development was 15 to 30 months after diagnosis; earlier time points were seen less frequently. Lymph node involvement was more common for carcinoma than for squamous cell carcinoma.

Anonymous Patient Answer
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