Catheterization for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate Cancer+9 MoreCatheterization - Procedure
Eligibility
18 - 80
Male
What conditions do you have?
Select

Study Summary

This trial will use PET to compare the prostate uptake of 68Ga-PSMA-11 delivered intra-arterially to that of the same agent delivered intravenously.

Eligible Conditions
  • Prostate Cancer
  • Stage IVB Prostate Cancer
  • Stage III Prostate Cancer
  • Stage II Prostate Cancer
  • Stage IIIB Prostate Cancer
  • Stage IV Prostate Cancer
  • Stage IVA Prostate Cancer
  • Prostate Adenocarcinoma
  • Stage IIIA Prostate Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Day 1 and from Day 2 up to Day 15 (2 days total)

1 day
Comparison of Mean SUV during 15-minute washout (SUVwashout)
Comparison of Time to early saturation effects
Day 15
Comparison of Area under the curve (AUC)
Comparison of Mass dose at saturation
Comparison of Mean SUV (SUVmean)
Comparison of Rate of 68Ga-PSMA-11 uptake
Comparison of Time to SUVmax (TSUV)
Maximum standardized uptake value (SUVmax)

Trial Safety

Trial Design

1 Treatment Group

Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization
1 of 1

Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: Catheterization · No Placebo Group · Phase < 1

Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial CatheterizationExperimental Group · 4 Interventions: Angiogram, Positron Emission Tomography, Catheterization, Gallium Ga-labeled PSMA-11 · Intervention Types: Procedure, Procedure, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2820
Catheterization
2015
N/A
~430

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 and from day 2 up to day 15 (2 days total)

Who is running the clinical trial?

Radiological Society of North AmericaOTHER
21 Previous Clinical Trials
4,804 Total Patients Enrolled
2 Trials studying Prostate Cancer
3,367 Patients Enrolled for Prostate Cancer
Ryan Kohlbrenner, MDLead Sponsor
Ryan KohlbrennerPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age 18 - 80 · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient must have at least 4 of 6 core biopsy sites showing Gleason 4+ disease
You are at least 18 years old and less than or equal to 80 years old.
You are able to provide informed consent.\n
You have a discrete lesion with maximal tumor diameter ≥ 2.0cm on at least one affected side, documented on prostate magnetic resonance imaging (MRI) or Transrectal ultrasound (TRUS) within 4 months of first scan.
Individuals over the age of 80 are excluded from this study to improve the likelihood of a catheterizable prostatic artery, given the higher rates of occlusive atherosclerosis with advanced age.