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18F-DCFPyL Imaging for Prostate Cancer

Phase 2

Recruiting

Led By Deborah E Citrin, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For individuals with a history of hepatitis C virus (HCV), the infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Must have at least 1 MRI detected, biopsy proven localized prostate cancer

Must not have

Contraindications to radiation or SBRT

Receiving prior androgen deprivation therapy, radiotherapy, or surgery for prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks after adt initiation (if applicable), 6 months post sbrt, at recurrence

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an imaging agent to see if it can help detect response to prostate cancer treatment.

Who is the study for?

This trial is for men aged 18+ with newly diagnosed localized prostate cancer, planning to undergo SBRT possibly with ADT. They must have an ECOG status of <=2, use contraception if applicable, and can't have prior prostate cancer treatments. HIV-positive participants are eligible if virally suppressed.

What is being tested?

Researchers are testing the effectiveness of a PET scan imaging agent called 18F-DCFPyL in detecting how well standard prostate cancer treatment works. Participants will undergo MRI and PET/CT scans before and after receiving SBRT (with or without ADT) to assess treatment response.

What are the potential side effects?

Possible side effects include reactions to the contrast agent used during MRI (like allergic reactions), discomfort from lying still during scans, and typical risks associated with IV injections such as pain or infection at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hepatitis C is cured or currently treated with no detectable virus.

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I have prostate cancer confirmed by MRI and biopsy.

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My hepatitis B virus load is undetectable with treatment.

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I have prostate cancer confirmed by biopsy and plan to undergo SBRT with or without hormone therapy.

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I am 18 years old or older.

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I am able to care for myself and perform daily activities.

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I have HIV but am on effective treatment with an undetectable viral load in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo radiation or SBRT due to health reasons.

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I have had hormone therapy, radiation, or surgery for prostate cancer.

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My cancer has spread beyond the prostate.

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I am scheduled for radiation therapy targeting the lymph nodes in my pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks after adt initiation (if applicable), 6 months post sbrt, at recurrence

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks after adt initiation (if applicable), 6 months post sbrt, at recurrence

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks after adt initiation (if applicable), 6 months post sbrt, at recurrence for reporting.