Recruiting EARLY_PHASE1 Prostate Carcinoma

New treatment option for Prostate Carcinoma

Official title 99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer

ClinicalTrials.gov ID: NCT04857502

What this study is testing

What is 99mTc-based PSMA Imaging and Surgery Agent?

99mTc-based PSMA Imaging and Surgery Agent is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate carcinoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I\&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I\&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc).
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Adults, men only

You may be able to join if

  • Men with PCa (primary or recurrent disease)
  • Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
  • Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
  • Men who are scheduled for pelvic LN dissection (PLND)
  • Men who can provide oral and written informed consent

You likely can't join if

  • Patients who started any PCa treatment between study enrollment and surgery
  • Technically inaccessible nodal location
See the full eligibility criteria
Who can join
  • Men with PCa (primary or recurrent disease)
  • Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
  • Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
  • Men who are scheduled for pelvic LN dissection (PLND)
  • Men who can provide oral and written informed consent
  • Men who can comply with study procedures
What rules you out
  • Patients who started any PCa treatment between study enrollment and surgery
  • Technically inaccessible nodal location

The study team makes the final eligibility decision.

Where it's taking place

  • Los Angeles, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, not specified. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.