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Cancer Vaccine

PSMA PET for Prostate Cancer (P-GAP Trial)

Phase 2

Recruiting

Research Sponsored by University of Alberta

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 through study completion, completion by end of study at 5 year mark. every 3 months for first year and every 6months-1 year after

Awards & highlights

P-GAP Trial Summary

This trial aims to determine if a new type of PET scan can be more accurate in staging prostate cancer compared to the standard MRI and biopsy. The study will enroll patients with unilateral prostate cancer who may benefit

Who is the study for?

Men over 50 with a PSA level under 15, diagnosed with unilateral prostate cancer of Gleason Grade Group 2 or 3 and clinical stage less than T2b. They should be eligible for focal therapy after standard diagnostic procedures.Check my eligibility

What is being tested?

This trial is testing the accuracy of a new PSMA PET scan against the usual MRI and biopsy methods in staging prostate cancer before focal therapy. Participants will either receive this new scan or no additional imaging to see if it better predicts who's suitable for treatment.See study design

What are the potential side effects?

Since this trial focuses on diagnostic techniques rather than treatments, side effects are minimal but may include discomfort from the PET scan procedure or reactions to tracers used in imaging.

P-GAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, completion by end of study at 5 year mark

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, completion by end of study at 5 year mark

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, completion by end of study at 5 year mark for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor Staging- Detection of any clinically significant prostate cancer

Secondary outcome measures

Early Economic analysis

Post Trial Economic analysis

Quality of Life Outcomes - AUA Symptom Score

+9 more

P-GAP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PSMA PETExperimental Treatment1 Intervention

These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will be randomized to undergo a single [18]F-PSMA-1007 PET/CT or PET/MRI scan prior to focal therapy. If they are diagnosed with bilateral disease, they will be ineligible for focal therapy and be referred for radical therapy. Those with unilateral disease will then proceed to focal therapy. They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation Intravenous bolus injection of 4 MBq/kg +/- 10% of [18]F-PSMA-1007, up to a maximum of 400 MBq.

Group II: No Additional ImagingActive Control1 Intervention

These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will undergo no further testing and will undergo focal therapy. They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation. Intravenous bolus injection of 4 MBq/kg +/- 10% of [18]F-PSMA-1007, up to a maximum of 400 MBq.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

384,920 Total Patients Enrolled

9 Trials studying Prostate Cancer

5,416 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

Is the process of enrolling participants still ongoing for this medical study?

"According to data from clinicaltrials.gov, this trial is actively seeking volunteers. The initial posting date was on April 2nd, 2024 and the most recent update occurred on April 15th, 2024."

Answered by AI

What is the upper limit of participants enrolled in this medical investigation?

"Affirmative. Information obtained from clinicaltrials.gov indicates that this study is presently in search of participants. The trial was initially posted on April 2nd, 2024 and most recently updated on April 15th, 2024. A total of 138 individuals are being sought across two designated sites for participation in the trial."

Answered by AI

Has the PSMA PET imaging technique received approval from the FDA?

"Our team at Power has assessed the safety of PSMA PET to be a 2 on our scale from 1 to 3. This rating is assigned because, being in Phase 2, there exists preliminary data supporting safety but not yet efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PSMA-Guided Ablation of the Prostate

Adam Kinnaird 2024. "PSMA-Guided Ablation of the Prostate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003556.