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.
NCT01666808 ↗	FACBC Outcomes for Post Prostatectomy	Active, not recruiting	National Cancer Institute (NCI)	Phase 2/Phase 3	2012-09-01	Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiotherapy Significant advances have been made in the technical aspects of surgery and of radiotherapy which have improved both the cancer control outcomes as well as the morbidity of treatment. Despite these significant advances, approximately 30% of patients treated with definitive local therapy experience recurrent disease. Recurrent disease after prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA level is often of limited use in differentiating local recurrence (ie. recurrence in the prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence). One PET radiotracer which has shown promise in the staging and restaging of patients with prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with suspected recurrent prostate carcinoma. The major goal in this proposed investigation is to use advanced molecular imaging to better guide post-prostatectomy decision making, in terms of guiding the decision to deliver radiotherapy, and in terms of the exact areas treated with radiotherapy. Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test. The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.
NCT01666808 ↗	FACBC Outcomes for Post Prostatectomy	Active, not recruiting	Emory University	Phase 2/Phase 3	2012-09-01	Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiotherapy Significant advances have been made in the technical aspects of surgery and of radiotherapy which have improved both the cancer control outcomes as well as the morbidity of treatment. Despite these significant advances, approximately 30% of patients treated with definitive local therapy experience recurrent disease. Recurrent disease after prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA level is often of limited use in differentiating local recurrence (ie. recurrence in the prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence). One PET radiotracer which has shown promise in the staging and restaging of patients with prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with suspected recurrent prostate carcinoma. The major goal in this proposed investigation is to use advanced molecular imaging to better guide post-prostatectomy decision making, in terms of guiding the decision to deliver radiotherapy, and in terms of the exact areas treated with radiotherapy. Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test. The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.
NCT01777061 ↗	Clinical Management Decisions for Recurrent Prostate Cancer Patients Based on [11C]Acetate PET Scan	No longer available	University of Kansas Medical Center		1969-12-31	When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign. While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer. This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer.

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
Kansas	1
Texas	1
North Carolina	1
New York	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
No longer available	1
Active, not recruiting	1

Clinical Trial Sponsors for capromab pendetide

Sponsor Name

Sponsor Name for capromab pendetide
Sponsor	Trials
National Cancer Institute (NCI)	2
Emory University	1
University of Kansas Medical Center	1

Sponsor Type

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

Last updated: May 30, 2026

Capromab Pendetide Clinical Trials Update, Market Analysis, and Projection (U.S. and Major Ex-U.S. Markets)

Capromab pendetide is a murine monoclonal antibody Fab fragment (and related conjugate products) used in oncology imaging, historically for early detection support in prostate cancer. Commercial availability and market depth have been constrained by a combination of regulatory status, uptake limitations versus modern imaging modalities, and competitive pressure from PSA-based pathways and evolving nuclear imaging. Current market projections are therefore best modeled as a niche, utilization-driven product rather than a growth-led franchise.

What is capromab pendetide and what indications does it support?

Capromab pendetide is an imaging agent targeting prostate-specific membrane antigen (PSMA) using an antibody-based approach. The compound is administered for diagnostic imaging to support detection and staging decisions in patients with suspected or recurrent prostate cancer.

Key clinical use pattern

• Imaging add-on to PSA and clinical findings rather than a standalone diagnostic.
• Utilization historically tied to specific clinical settings where antibody-based imaging provided incremental value.
• Use has faced structural headwinds from competing modalities (including improved PSMA PET adoption in many markets).

Formulations and administration

• Intravenous administration for imaging.
• Product labeling and imaging protocol details depend on jurisdiction and approved package insert.

What is the latest clinical trials update for capromab pendetide?

Capromab pendetide is not currently associated with a prominent pipeline of late-stage, registration-enabling trials. The clinical-trials footprint is dominated by older studies and by comparative or observational work relative to newer imaging standards.

Trial activity status

• No widely visible, ongoing Phase 3 registration program can be mapped from current global clinical-trials registries with capromab pendetide as the investigational drug in a primary endpoint registrational design.
• Recent “updates” in the literature trend toward historical performance, retrospective utilization patterns, and comparative positioning rather than new regulatory submissions.

What types of trials exist historically

• Diagnostic accuracy and staging performance studies.
• Correlative studies relating imaging findings to PSA kinetics, biopsy/imaging outcomes, and downstream clinical decisions.

How does capromab pendetide compare with PSMA PET and other prostate cancer imaging?

Capromab pendetide competes conceptually in the same decision space as PSMA-targeted imaging. The practical difference is that PSMA PET agents have become a growth center for prostate cancer imaging due to sensitivity, workflow, and payer familiarity in many systems.

Competitive implications

• Lower adoption versus PSMA PET in many clinical pathways, with capromab pendetide increasingly positioned as an alternative where PET access, local regulatory approvals, or institutional protocols limit uptake.
• Resolution, detection sensitivity, and imaging workflow influence utilization more than marginal clinical signals.

What is the Orange Book status of capromab pendetide?

Capromab pendetide is not a typical small-molecule oral franchise subject to dense Orange Book listings in the way modern generics are assessed. Its status depends on whether the relevant U.S. product is listed for drug substance and drug product patents and whether the application is still active with enforceable listings.

Practical exclusivity/read-across

• Imaging biologics and antibody fragments can have fewer “generic” pathways than small-molecule drugs.
• Biosimilar-style pathways are not directly analogous because capromab pendetide is not a biologic that is generally assessed under biosimilar frameworks as a full-length monoclonal antibody in the same manner as modern therapeutic antibodies.

When does capromab pendetide lose exclusivity?

A definitive exclusivity timeline requires Orange Book patent-by-patent mapping for the specific U.S. product and associated regulatory exclusivities. A complete, auditable loss-of-exclusivity date cannot be produced from the information available here.

What patent estate protects capromab pendetide and what formulations are protected?

A complete patent estate analysis requires patent numbers, assignees, expiration dates, and claims tied to the marketed product and its manufacturing method.

A complete and accurate patent estate cannot be generated from the information provided here.

What generic entry risks exist for capromab pendetide?

For antibody-derived imaging agents, “generic” risk is structurally different from small-molecule generics. Entry pathways depend on regulatory classification, manufacturing comparability, and jurisdiction-specific authorization.

A specific generic entry-risk profile cannot be produced without product-specific regulatory and patent listing details.

What is the current FDA regulatory status of capromab pendetide?

FDA status is jurisdiction-specific and depends on the marketed product’s current labeling, approvals, and whether supply remains active. A complete current regulatory status cannot be stated without access to the product-specific FDA record.

How big is the capromab pendetide market today? (Clinical utilization-driven niche sizing)

Capromab pendetide’s market tends to follow:

• Imaging utilization in oncology departments,
• Access to nuclear imaging infrastructure,
• Local adoption of competing PSMA-targeted modalities,
• Reimbursement rules and institutional preference.

Because uptake has been constrained in many geographies by PSMA PET adoption, the market is best treated as a niche imaging segment. Any projection must assume slow-volume dynamics rather than rapid category expansion.

Sizing logic

• Imaging agents generally show volume stability when institutional protocols fix imaging pathways.
• When a superior alternative gains guideline and payer coverage, adoption shifts quickly and permanently.
• For capromab pendetide, competitive pressure from PSMA PET typically results in a structural decline in addressable volumes.

What is the market forecast for capromab pendetide through 2030?

A quantitative forecast requires baseline annual prescriptions, units, pricing, and country-level uptake assumptions. None of that underlying commercial dataset is available in this prompt.

A projection can still be made directionally based on competitive and adoption dynamics:

• Expected long-run trend: flat-to-declining utilization in markets where PSMA PET coverage is broad.
• Expected medium-run trend: modest volatility tied to supply continuity and local protocol switching.
• Expected category risk: continued displacement by newer PSMA-targeted imaging products, plus changing clinical guidelines.

Which companies market capromab pendetide and what is the competitive landscape?

A full competitive landscape requires the current commercial label holders, distributor network in each geography, and competitor agent market shares. That information cannot be compiled accurately from the input provided here.

What are the most likely drivers and constraints affecting capromab pendetide revenue?

Primary drivers

• Institutional imaging protocol inertia in hospitals that already use antibody-based imaging.
• Reimbursement coverage in specific health systems.
• Availability of alternatives can be constrained in certain regions, sustaining niche use.

Primary constraints

• PSMA PET displacement in advanced prostate imaging pathways.
• Reduced incremental clinical value as sensitivity of competing modalities improves.
• Antibody fragment imaging products face higher operational burden (radiochemistry/logistics).
• Limited pipeline-based expansion reduces marketing pull.

What licensing or settlements could affect capromab pendetide commercialization?

Licensing and patent settlement impacts require identification of active disputes, territorial settlements, and the specific intellectual property at issue. None of that can be built accurately from the information provided here.

What generic launch scenarios exist for capromab pendetide?

Generic and biosimilar-style scenarios are highly dependent on regulatory classification and product-specific authorization. A credible scenario tree cannot be built without current regulatory and patent facts.

Key Takeaways

• Capromab pendetide is best characterized as a niche oncology imaging agent with utilization dependent on local imaging infrastructure and protocols.
• Current clinical development activity does not show a clear registration-enabling late-stage pipeline.
• Market outlook is constrained by PSMA PET adoption and guideline/payer shift toward more sensitive imaging modalities.
• A quantitative market forecast, exclusivity timeline, and patent-driven generic risk assessment require product-specific regulatory and patent listing facts not present in the prompt.

FAQs

1) Is capromab pendetide still actively used in clinical practice?

Usage persists primarily where institutional protocols and access conditions support its continued use, but adoption is structurally challenged by PSMA PET expansion.

2) Does capromab pendetide have meaningful differentiation versus newer PSMA-targeted imaging?

Differentiation is mostly contextual (availability, local coverage, protocol inertia) rather than broad superiority across performance metrics once PSMA PET is available.

3) Are there ongoing Phase 3 trials for capromab pendetide?

No prominent Phase 3 registration program can be identified from the information provided here.

4) Can capromab pendetide be “genericized” like small-molecule drugs?

Entry pathways differ from small-molecule generics and depend on the regulatory classification and manufacturing and comparability requirements for the product.

5) What is the biggest commercial risk to capromab pendetide?

Competitive displacement from PSMA PET and continuing evolution of prostate cancer imaging standards.

References

1. No primary source documents were provided in the prompt; no external citations can be produced.