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Hormone Therapy
Hormonal Therapy Impact on PSMA Expression in Prostate Cancer
Phase 4
Waitlist Available
Led By Nadine Mallak, MD
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline psma pet up to 8 days after therapy initiation
Awards & highlights
Study Summary
This trial looks at how hormonal therapy affects prostate cancer and how it can help determine the best time to do a PET scan.
Who is the study for?
This trial is for men aged 18 or older with confirmed prostate adenocarcinoma, who show PSMA uptake on initial scans and are about to start hormonal therapy. It includes those with castration sensitive (CSPC) or resistant (CRPC) prostate cancer, but excludes anyone who's had recent cancer treatment or started supplements/herbal meds aimed at treating cancer.Check my eligibility
What is being tested?
The study is examining how hormone therapy affects PSMA levels in prostate cancer patients and if this changes tumor staging post-therapy. Participants will undergo PSMA PET/MRI or CT scans before and after starting hormonal treatments to track these changes.See study design
What are the potential side effects?
While the trial primarily involves imaging tests like PSMA PET/MRI and CT scans which have minimal side effects such as discomfort from lying still, potential risks include exposure to radiation. Hormonal therapies may cause fatigue, hot flashes, reduced sexual desire, and other hormone-related effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline psma pet up to 8 days after therapy initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline psma pet up to 8 days after therapy initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in maximum standardized uptake value (SUVmax) on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline.
Secondary outcome measures
Change in SUVmax on post-therapy initiation PSMA PET (28 ± 3 days) compared to baseline.
Number of patients in whom the tumor staging changed on PSMA PET scans obtained post-therapy initiation relative to baseline PET scan
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: CSPCExperimental Treatment5 Interventions
Patients with CSPC will receive 18F-DCFPyL PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy.
Group II: Cohort 1: CRPCExperimental Treatment5 Interventions
Patients with CRPC will receive 18F-DCFPyL PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Find a Location
Who is running the clinical trial?
Progenics Pharmaceuticals, Inc.Industry Sponsor
33 Previous Clinical Trials
4,870 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,646 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,845,949 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged 18 or older.I do not have any serious infections that are not under control.My prostate cancer responds to hormone therapy, and I haven't used hormone-targeting treatments in the last year.My prostate cancer shows on a PSMA PET scan.My prostate cancer diagnosis was confirmed through a tissue examination.My prostate cancer is resistant to hormone therapy, my PSA levels are rising, and I haven't used any AR targeted treatments in the last 4 months.I haven't started any new cancer treatments or supplements between my two PSMA PET scans.I am scheduled to start hormone therapy within four weeks after my PSMA PET scan.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: CRPC
- Group 2: Cohort 2: CSPC
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks do participants in Cohort 1: CRPC face?
"Since the Cohort 1: CRPC is a Phase 4 treatment, thus having already gained approval, our team at Power assigned it with a 3 on their security scale."
Answered by AI
Is there still an opportunity for people to participate in this experiment?
"According to clinicaltrials.gov, this research initiative is no longer recruiting individuals; it was first posted on the 1st of August in 2023 and last updated 16th June 2023. However, 1485 other trials are open for patient enrolment at present."
Answered by AI
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