CLINICAL TRIAL

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone for Prostate Cancer

Metastatic
Recruiting · Any Age · Male · New York, NY

This study is evaluating whether a type of x-ray test may be better able to find places in the body where your prostate cancer may have spread.

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About the trial for Prostate Cancer

Eligible Conditions
Prostatic Neoplasms · Prostate Cancer

Treatment Groups

This trial involves 2 different treatments. [18F]-Fluoro-2-Deoxy-D-Glucose And -[18F] Dihydro-Testosterone is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for male patients of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients with histologically confirmed prostate cancer.
Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease. Or Biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.
Visible lesions by either CT, bone imaging, or MRI consistent with disease.
Informed consent.
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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: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
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 [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone will improve 1 primary outcome and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Baseline. 4 weeks and 12 weeks.

The kinetics, metabolism, and biodistribution will be assessed.
BASELINE. 4 WEEKS AND 12 WEEKS
BASELINE. 4 WEEKS AND 12 WEEKS
To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer. The accumulation and location of FDHT activity will be assessed on a site by site basis and correlated with radionuclide bone scan, CT and MRI.
BASELINE, 4 WEEKS AND 12 WEEKS
BASELINE, 4 WEEKS AND 12 WEEKS
To correlate the accumulation of 18FDHT to 18FDG.
2 YEARS
2 YEARS
relationship between FDHT uptake and tissue analyses
2 YEARS
of AR expression
2 YEARS
relationship between FDHT uptake and tumor diffusivity
2 YEARS
assessed by MRI.
2 YEARS
To study changes in 18FDHT accumulation over time in patients treated with: Castration and other hormones, Chemotherapy, Agents directed toward the androgen receptor
2 YEARS
2 YEARS

Patient Q & A Section

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

How many people get prostate cancer a year in the United States?

Approximately 75000 men and boys receive a diagnosis of prostate cancer in the United States each year. Younger men have a considerably higher incidence of getting prostate cancer than old men and this difference becomes more evident among blacks, Hispanics, and other minority individuals.

Anonymous Patient Answer

Can prostate cancer be cured?

Results from a recent clinical trial presented here do not support the possibility of curative treatment of prostate cancer that does not cause the death of any of the patients in this study. Results from a recent clinical trial provides weak evidence for the suggestion that palliative treatment could be curative. More studies are required to substantiate this contention.

Anonymous Patient Answer

What is prostate cancer?

Symptoms of prostate cancer have been known since ancient Egypt. Over 200 years, the signs and symptoms of prostate cancer have also been known, but the disease was thought to be incurable until 1975.

Anonymous Patient Answer

What causes prostate cancer?

Prostate cancer affects some men and is not a single disease with a clear cause. However, men who have recently consulted a GP and were diagnosed with prostate cancer and/or consulted with a specialist urologist do have more issues with their health than men of equal ages from the general population. These men should be counselled by their doctor to seek help and to discuss risks with their doctor when possible. If a doctor fails to do this, they must offer the man a better chance to live a healthier life by educating him about the risks of prostate cancer, and encourage them to consult their doctor about this condition.

Anonymous Patient Answer

What are common treatments for prostate cancer?

While the first-line treatment for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is a surgical removal of prostate tissue (prostatectomy), radiation therapy (brachytherapy or external beam radiation) or androgen deprivation therapy in combination with definitive treatment such as radical prostatectomy, is also often used as adjunctive therapy or salvage therapy. The second-line treatment is hormonal deprivation such as antiandrogen monotherapy or combined therapy with androgen deprivation and adjuvant chemotherapy. Androgen deprivation therapy in combination with androgen receptor antagonist monotherapy is also usually used as adjuvant therapy. Radiation and androgen deprivation therapy is also used in combination with hormone-sensitive antagonists (hormonal agents) in salvage therapy.

Anonymous Patient Answer

What are the signs of prostate cancer?

Increased levels of PSA, a biochemical marker of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), are often found in older men, particularly in the absence of symptoms of any other medical condition. There is no conclusive evidence that increases in PSA levels and the risk of developing prostate cancer are an early sign of cancer.

Anonymous Patient Answer

Who should consider clinical trials for prostate cancer?

Men presenting with symptoms of BPH, lower urinary tract symptoms, or a PSA of 10 ng/mL or greater or with a life expectancy of less than 10 years had a high probability of having [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). Only a limited percentage of the patients who presented with BPH have prostate cancer and the vast majority of patients with BPH have low cancer risk and can be managed by watchful waiting. Therefore, patients with BPH, lower urinary tract symptoms, a serum PSA above 10 ng/mL, and a life expectancy of less than 10 years should consider enrolment in clinical studies. However, a significant proportion of the patients with BPH who are not bothered by their symptoms are candidates for and may benefit from clinical trials for prostate cancer.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

The average age of first prostate cancer diagnosis in men in Scotland is 81 years. This means that a fifth of those diagnosed will be over 90 upon diagnosis, and that prostate cancer will be diagnosed for the first time at a later age than the general population. As prostate cancer is highly variable in its rate of progression the age at diagnosis should remain a critical factor for determining future patient management.

Anonymous Patient Answer

What is [18f]-fluoro-2-deoxy-d-glucose and -[18f] dihydro-testosterone?

Taken together, [(18)F]-F-FDG and [(18)F]DHT PET imaging is useful for imaging human prostate tumors at a high resolution; [(18)F]DHT is, however, at significantly greater level of tumoral FDG uptake and tumor to blood SUV. It is the objective of our current studies to determine whether [(18)F]DHT, is useful as an alternative imaging tracer of testosterone and DHT content in prostate tumors.

Anonymous Patient Answer

Is [18f]-fluoro-2-deoxy-d-glucose and -[18f] dihydro-testosterone typically used in combination with any other treatments?

FEDG is typically used by itself in patients after radical prostatectomy. The addition of estrogens to minimize androgen deprivation is practiced less frequently. HSDG is typically used in combination with the administration of estrogen. A common combination of androgen deprivation with estrogen use is to use FEDG followed by HSDG in both men and women.

Anonymous Patient Answer

How quickly does prostate cancer spread?

Prostate cancer is found in up to 10% of patients with other localized cancers, which may be related to earlier diagnosis on prostate biopsy. The presence of lymph node and distant metastases does not preclude curability of prostate cancer, as evidenced by the lack of correlations of these factors with survival. Findings from a recent study of the present analysis demonstrate that the spread of prostate cancer is more variable than previously believed.

Anonymous Patient Answer

What is the survival rate for prostate cancer?

Current treatments for prostate cancer provide men with longer survival than previously believed. The 5-year postdiagnosis survival rate for prostate cancer varies according to the stage at which the patient was diagnosed. Patients with early stage disease (locally confined disease) have a survival rate that is similar to a general population. However, those who have recently been diagnosed with late stage disease (metastatic disease) have the shortest life expectancies.

Anonymous Patient Answer
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