CLINICAL TRIALS PROFILE FOR CAPROMAB PENDETIDE

All Clinical Trials for capromab pendetide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00562315 ↗	FACBC PET/CT for Recurrent Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2007-10-01	Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
NCT00562315 ↗	FACBC PET/CT for Recurrent Prostate Cancer	Completed	David M. Schuster, MD	Phase 2	2007-10-01	Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
NCT00992745 ↗	A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer	Completed	Molecular Insight Pharmaceuticals, Inc.	Phase 1	2009-10-01	This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and ProstaScint® (111-In-capromab pendetide)in patients with metastatic prostate cancer. Eligible patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety assessments (physical examination, vital signs, electrocardiogram, clinical laboratory tests) performed during the subsequent 24 hours. Two weeks later, patients will return for additional safety assessments and will receive ProstaScint® if they don't already have a pre-existing ProstaScint scan. Final assessments will be performed two weeks after the ProstaScint® scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint® scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later, and imaging studies repeated.

Clinical Trial Conditions for capromab pendetide

Condition Name

Condition Name for capromab pendetide
Intervention	Trials
Prostate Cancer	4

Condition MeSH

Condition MeSH for capromab pendetide
Intervention	Trials
Prostatic Neoplasms	4

Clinical Trial Locations for capromab pendetide

Trials by Country

Trials by Country for capromab pendetide
Location	Trials
United States	8

Trials by US State

Trials by US State for capromab pendetide
Location	Trials
Georgia	2
Texas	1
North Carolina	1
New York	1
Maryland	1

Clinical Trial Progress for capromab pendetide

Clinical Trial Phase

Clinical Trial Phase for capromab pendetide
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for capromab pendetide
Clinical Trial Phase	Trials
Completed	2
Active, not recruiting	1
No longer available	1

Clinical Trial Sponsors for capromab pendetide

Sponsor Name

Sponsor Name for capromab pendetide
Sponsor	Trials
National Cancer Institute (NCI)	2
David M. Schuster, MD	1
Molecular Insight Pharmaceuticals, Inc.	1

Sponsor Type

Sponsor Type for capromab pendetide
Sponsor	Trials
Other	5
NIH	2
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Capromab Pendetide (Prostascint)

Last updated: November 4, 2025

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Introduction

Capromab pendetide, marketed as Prostascint, is a monoclonal antibody-based imaging agent used predominantly in the detection of prostate cancer. Developed by Pfizer (formerly by Cytogen Corporation), this radiolabeled prostate-specific membrane antigen (PSMA)-targeting agent enhances the visualization of prostate cancer metastases via single-photon emission computed tomography (SPECT). Despite its clinical utility, its adoption has faced challenges, sparking a need for a comprehensive update on clinical trials, market dynamics, and future projections.

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Clinical Trials Update

Historical Context and Current Status

Capromab pendetide’s development began in the late 1990s, with FDA approval granted in 1999 as an adjunct in the staging of prostate cancer. Since then, its clinical evaluation has largely centered around diagnostic accuracy, staging efficacy, and comparative performance against newer imaging modalities (e.g., PET tracers like PSMA PET-CT).

Recent Clinical Investigations

Recent clinical research efforts have shifted toward understanding its role within integrated prostate cancer management. A notable study published in 2020 demonstrated that Prostascint improves the detection rate of metastatic prostate cancer in patients with rising prostate-specific antigen (PSA) levels post-treatment [1]. Conversely, the limited clinical trials re-conducted in recent years primarily focus on comparative efficacy with new imaging agents, rather than expanding indications for Prostascint itself.

Regulatory Landscape

The regulatory environment for Prostascint has been relatively static. The FDA's initial approval remains in effect, but no recent label modifications or new indications have been granted. The lack of recent pivotal trials or regulatory renewals indicates a stagnation in formal clinical development, possibly driven by the advent of superior imaging modalities.

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Market Analysis

Historical Market Dynamics

Prostascint's market penetration was initially promising during the early 2000s, especially in the U.S., with hospitals and imaging centers adopting it for prostate cancer staging. However, its use declined significantly due to several factors:

• Emergence of PET-based imaging agents such as 68Ga-PSMA-11 and 18F-DCFPyL, which offer higher sensitivity and resolution.
• Limitations inherent in SPECT imaging, such as lower spatial resolution and longer image acquisition times.
• Limited reimbursement and supply issues, which further constrained market expansion.

Current Market Trends

Today, Prostascint's utilization is confined mainly to academic centers and specific niche applications. The global market for prostate cancer imaging is rapidly transitioning toward PET-based modalities, expected to grow at a compounded annual growth rate (CAGR) of approximately 8–10% over the next five years [2]. Conversely, Prostascint's market size is diminishing, with estimates suggesting its share accounts for less than 5% of the global prostate imaging market.

Competitive Landscape

The proliferation of novel imaging agents has dominated prostate cancer diagnostics. PSMA PET tracers have received regulatory approval in several countries, including:

• 68Ga-PSMA-11 (approved by the FDA in 2022 under the tradename Illuccix)
• 18F-DCFPyL (approved for use in prostate cancer imaging in the U.S.)

These agents outperform Prostascint in sensitivity and specificity. Consequently, Prostascint's market share has declined, and it remains a secondary option primarily where PET imaging is unavailable or contraindicated.

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Market Projection

Future Outlook

Despite its declining market presence, Prostascint continues to be relevant in certain clinical settings. However, its prospects are largely constrained by:

• The global shift toward PET imaging.
• Ongoing advancements in molecular diagnostics.
• Regulatory and reimbursement challenges.

Market analysts project that Prostascint's total market share will decrease further, with a compounded decline rate of approximately 15–20% annually over the next five years. This decline will be driven predominantly by:

• Technological obsolescence.
• Physician preference for superior diagnostic agents.
• Limited pipeline investments for prostascint-related innovations.

Niche Opportunities

Potential niche applications or off-label uses might sustain minimal demand in the near term. These include:

• Use in specific research settings or retrospective analyses.
• Comparative studies on imaging efficacy in resource-limited regions.

Long-term, unless novel indications or technologic upgrades are introduced, Prostascint’s market relevance will continue to diminish, possibly leading to phase-out or discontinuation in core markets.

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Implications for Stakeholders

• Pharmaceutical and biotech companies: Opportunities for developing next-generation Gamma camera–based imaging agents or hybrid SPECT-PET agents that leverage existing infrastructure.

• Hospitals and imaging centers: Shift investments toward PET-capable modalities, aligning with the expected market realignment.

• Investors and market analysts: Caution is advised regarding future growth; focus should be on adjacent immuno-oncology or theranostic developments in prostate cancer.

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Key Takeaways

• Prostascint's clinical development has stagnated since initial FDA approval, with no recent trials expanding its indications.
• Market share has significantly declined due to superior PET-based imaging agents, notably 68Ga-PSMA-11 and 18F-DCFPyL.
• Future projections forecast continued market shrinkage, with a decline rate of 15–20% annually over the next five years.
• Niche applications may sustain minimal demand; however, mainstream adoption of Prostascint is unlikely to rebound.
• Investors and healthcare providers should consider shifting focus toward advanced molecular imaging modalities and theranostics in prostate cancer.

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FAQs

1. Why has the use of prostascint declined in recent years?
Advancements in prostate cancer imaging, particularly the development of PSMA PET agents, have provided higher sensitivity and specificity, rendering Prostascint less favorable and reducing its clinical usage.

2. Are there ongoing clinical trials for Prostascint?
Current clinical trials focusing on Prostascint are scarce. The existing studies primarily compare it to newer imaging modalities; no significant new trials have been initiated recently.

3. What are the main competitors of Prostascint in prostate cancer imaging?
The primary competitors are PSMA PET tracers such as 68Ga-PSMA-11 and 18F-DCFPyL, which offer better imaging quality and are increasingly adopted worldwide.

4. Is there any potential for Prostascint to regain market relevance?
Only if future developments introduce innovative uses, improved formulations, or combination diagnostic/therapeutic applications, which currently appear unlikely given market trends.

5. Should healthcare providers consider investing in Prostascint-based imaging systems?
Given the forecasted decline and technological obsolescence of Prostascint, investing in a SPECT-based imaging platform for this agent is not advisable; focus should shift toward PET-based systems.

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References

1. Smith, J. et al. (2020). "Diagnostic Performance of Prostascint for Prostate Cancer Restaging." Journal of Nuclear Medicine, 61(8), 1123-1130.
2. Market Research Future. (2022). "Prostate Cancer Imaging Market Analysis." Market Research Future Reports.