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PSMA-based PET Imaging for Prostate Cancer

Phase < 1
Waitlist Available
Led By Theodore DeWeese, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostate biopsy histology grade ≥ Gleason 8-10
Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and then at 2-3 months
Awards & highlights

Study Summary

This trial is testing a new radiotracer to see if it can help find prostate cancer.

Who is the study for?
This trial is for men over 18 with newly diagnosed prostate cancer, graded Gleason 8-10, who are planning to have radiation and ADT. They must be medically fit for these treatments and at least 10 days post-prostate biopsy. Men already on hormone therapy or those who've had chemotherapy, investigational therapies, or prior pelvic radiation can't participate.Check my eligibility
What is being tested?
The study tests a new radioactive imaging agent called 18F-DCFPyL in detecting prostate cancer within the gland and elsewhere in the body before surgery. It aims to improve how we visualize cancer using PET-MRI fusion techniques.See study design
What are the potential side effects?
Potential side effects may include reactions related to the radiotracer such as discomfort at injection site or allergic reactions, plus typical MRI-related issues like claustrophobia or discomfort from lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is aggressive (Gleason score 8-10).
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I am a man over 18 with new prostate cancer, planning on radiation and hormone therapy.
Select...
I have been recently diagnosed with prostate cancer confirmed by a biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and then at 2-3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and then at 2-3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate differences
Secondary outcome measures
All cause DCFPyL PET-MRI fusion or PET/MRI toxicity
Biomarker changes
Gene expression changes
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: DCFPyL PET-MRI fusion or PET/MRIExperimental Treatment1 Intervention
Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months of ADT Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,655 Previous Clinical Trials
40,933,196 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,877 Total Patients Enrolled
57 Trials studying Prostate Cancer
3,348 Patients Enrolled for Prostate Cancer
Theodore DeWeese, M.D.Principal InvestigatorThe SKCCC at Johns Hopkins
1 Previous Clinical Trials
45 Total Patients Enrolled
1 Trials studying Prostate Cancer
45 Patients Enrolled for Prostate Cancer

Media Library

Pelvic DCFPyL PET-MRI fusion or PET/MRI Clinical Trial Eligibility Overview. Trial Name: NCT02420977 — Phase < 1
Prostate Cancer Research Study Groups: DCFPyL PET-MRI fusion or PET/MRI
Prostate Cancer Clinical Trial 2023: Pelvic DCFPyL PET-MRI fusion or PET/MRI Highlights & Side Effects. Trial Name: NCT02420977 — Phase < 1
Pelvic DCFPyL PET-MRI fusion or PET/MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT02420977 — Phase < 1

Frequently Asked Questions

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

How many participants can the maximum capacity of this trial accommodate?

"Affirmative, the information on clinicaltrials.gov suggests that this experiment is actively recruiting patients. It was initially posted on December 6th 2018 and its most recent update arrived October 12th 2022. Researchers need to select 23 individuals from a single location for participation in the trial."

Answered by AI

Who meets the criteria to join this experiment?

"This clinical trial seeks 23 males aged 18-100 who were recently diagnosed with prostate cancer and are scheduled to undergo radiation therapy in combination with ADT. To qualify, individuals must meet the outlined inclusion criteria listed on the study's application page."

Answered by AI

Is the eligibility criterion for this research restricted to those under 25?

"This specific medical trial has outlined that the age limit for participants is 18 to 100. Additionally, there are 72 trials available for minors and 1249 other studies open to seniors aged over 65 years old."

Answered by AI

Is enrollment open for participants in this clinical trial?

"Clinicaltrials.gov reveals that this project is actively recruiting, having been posted to the public on December 6th 2018 and last updated on October 12th 2022."

Answered by AI
~0 spots leftby Jun 2024