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.

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
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

Capromab Pendetide: Clinical Trials, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Capromab pendetide is an investigational antibody-based radiopharmaceutical for prostate cancer. This analysis reviews its current clinical trial status, assesses the market landscape for prostate cancer therapeutics, and projects future market engagement for capromab pendetide.

What is the Current Clinical Trial Status of Capromab Pendetide?

Capromab pendetide, also known as Cygus® (and previously as ProstaScint® and Lumimune®), is a murine monoclonal antibody that targets prostate-specific membrane antigen (PSMA). It is conjugated with the radionuclide Indium-111 for imaging or with Iodine-131 for therapy [1].

Key Clinical Developments:

• Imaging Application: Capromab pendetide was historically used as an imaging agent (ProstaScint®) to detect prostate cancer recurrence or metastasis. Regulatory approval for this indication has faced challenges and market withdrawal in some regions due to limitations in specificity and sensitivity compared to newer imaging modalities [2].
• Therapeutic Application: The primary focus of current development is its therapeutic potential, particularly for metastatic castration-resistant prostate cancer (mCRPC) and potentially biochemically recurrent prostate cancer.
  • Phase III Trials: While past Phase III trials for imaging demonstrated mixed results, leading to its limited market presence in that capacity, ongoing research explores its efficacy as a standalone therapeutic or in combination therapies [3].
  • Ongoing Research: Current investigations are evaluating capromab pendetide's ability to deliver targeted radiation to PSMA-expressing tumor cells. This includes studies assessing its safety, tolerability, and efficacy in patients with advanced disease [4]. Specific trial arms are examining dose escalation, combination with chemotherapy or other targeted agents, and its role in different stages of prostate cancer progression.
  • Biomarker Dependence: The efficacy of capromab pendetide is directly linked to the expression of PSMA on tumor cells. PSMA expression is generally high in prostate cancer, increasing with disease progression and grade, making it a suitable target [1].
• Regulatory Pathways: The drug has undergone review by regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The path to approval for therapeutic indications is contingent on demonstrating significant clinical benefit over existing standards of care [2].

What is the Market Landscape for Prostate Cancer Therapeutics?

The prostate cancer therapeutics market is substantial and growing, driven by an aging global population, increasing cancer incidence, and advancements in diagnosis and treatment.

Market Size and Growth:

• Global Market Value: The global prostate cancer market was valued at approximately $15.1 billion in 2022 and is projected to reach $26.1 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 7.1% from 2023 to 2030 [5].
• Key Drivers:
  • Aging Population: The incidence of prostate cancer significantly increases with age, making the expanding elderly demographic a primary driver of market growth.
  • Technological Advancements: Improved diagnostic tools, including advanced imaging (e.g., PSMA PET/CT), and the development of novel therapeutic agents (e.g., targeted therapies, immunotherapies, radiopharmaceuticals) are expanding treatment options and market demand.
  • Increased Awareness and Screening: Greater public awareness and more effective screening programs lead to earlier detection and a larger patient population eligible for treatment.
  • Rising Healthcare Expenditure: Increased spending on healthcare globally, particularly in developed economies, supports market expansion.

Major Therapeutic Segments:

The prostate cancer market encompasses several treatment modalities:

1. Hormone Therapy (Androgen Deprivation Therapy - ADT): This remains a cornerstone for advanced prostate cancer, targeting the hormonal dependence of cancer growth. Key drugs include GnRH agonists/antagonists (e.g., leuprolide, degarelix) and anti-androgens (e.g., enzalutamide, abiraterone acetate). This segment represents a significant portion of the current market.
2. Chemotherapy: Drugs like docetaxel and cabazitaxel are used for castration-resistant prostate cancer (CRPC) and symptomatic disease.
3. Targeted Therapy: Agents targeting specific genetic mutations or pathways are emerging, though less prevalent than hormone therapy.
4. Radiopharmaceuticals: This is a rapidly growing segment. Lutetium-177-based PSMA-targeted therapies (e.g., lutetium-177 vipivotide tetraxetan (Pluvicto®) and 177Lu-PSMA-617) have demonstrated significant efficacy in mCRPC and are gaining traction.
5. Immunotherapy: While less established than in other cancers, some immunotherapies are being explored for prostate cancer.
6. Surgery and Radiation Therapy: These are primary treatments for localized disease but fall outside the scope of pharmaceutical market analysis.

Competitive Landscape:

The market is characterized by established pharmaceutical companies and emerging biotechs. Key players include:

• Endocrine Therapy: Astellas Pharma (Xtandi®), Johnson & Johnson (Zytiga®), Pfizer (Xtandi®), Bayer (Nubeqa®), AbbVie (Lupron Depot®).
• Chemotherapy: Sanofi (Jevtana®), Sanofi-Aventis (Taxotere®).
• Radiopharmaceuticals: Novartis (Pluvicto®), Telix Pharmaceuticals (Illuccix® - imaging agent, potentially therapeutic in future).
• Imaging Agents: Advanced PSMA PET tracers are becoming standard, impacting the role of older imaging agents.

Unmet Needs:

Despite advancements, significant unmet needs persist, especially in advanced and refractory disease:

• Treatment Resistance: Patients often develop resistance to standard hormone therapies and chemotherapies.
• Limited Options for Early Recurrence: Effective treatment options for biochemically recurrent prostate cancer before overt metastasis are still developing.
• Improved Targeted Therapies: Development of agents with higher efficacy and better safety profiles.
• Durable Responses: Achieving long-term, sustained disease control.
• Combination Strategies: Optimizing combinations of existing and novel therapies.

How Will Capromab Pendetide Engage the Market?

Capromab pendetide's market engagement will be primarily defined by its therapeutic efficacy, regulatory approval status, and its positioning relative to emerging PSMA-targeted radiopharmaceuticals.

Strategic Considerations:

1. Therapeutic Efficacy in mCRPC: The drug's success hinges on demonstrating superior or comparable efficacy and safety to existing treatments, particularly to established hormone therapies and emerging radioligand therapies like 177Lu-PSMA-617. Data from ongoing Phase III trials will be critical.
2. Comparison to 177Lu-PSMA Therapies: Capromab pendetide, as an Iodine-131-based therapeutic, will be directly compared against Lutetium-177-based therapies. While both target PSMA, differences in radioisotope characteristics (e.g., emission type, range of radiation) and clinical outcomes will determine market share. Lutetium-177 therapies have shown promising results in PSMA-positive mCRPC patients previously treated with AR-targeted therapy and taxane chemotherapy [6].
3. Dosage and Administration: The administration protocol, including dosing frequency, delivery method, and the infrastructure required for handling radioisotopes, will influence its practical adoption. Iodine-131 is a beta and gamma emitter, requiring specific handling and potentially leading to different side effect profiles compared to Lutetium-177, which is primarily a beta emitter with some gamma emission for imaging.
4. Patient Selection and Biomarker Status: Precise identification of PSMA-expressing tumors using PET imaging (e.g., 68Ga-PSMA-11 PET/CT) is paramount for patient selection. Capromab pendetide is expected to be prescribed for PSMA-positive disease, aligning with the trend towards precision medicine.
5. Market Penetration in Recurrent Disease: Beyond mCRPC, there is potential for capromab pendetide in biochemically recurrent prostate cancer. If trials demonstrate efficacy in delaying progression or reducing the need for systemic therapy in this earlier setting, it could capture a significant market segment.
6. Combination Therapies: Its potential integration into combination treatment regimens, alongside chemotherapy, hormone therapy, or other targeted agents, could expand its utility and market reach. Research into synergistic effects will be vital.
7. Re-emergence as an Imaging Agent: While its historical use as an imaging agent was limited, advancements in understanding PSMA expression and potential improvements in its formulation or diagnostic capabilities could theoretically lead to a re-evaluation for specific diagnostic niches, though this is less likely given the dominance of PSMA PET tracers.
8. Manufacturing and Supply Chain: The ability to reliably manufacture and distribute capromab pendetide, particularly the radioisotope component, will be a key logistical consideration impacting market availability.

Projected Market Position:

Assuming successful clinical trials and regulatory approvals for therapeutic use, capromab pendetide could establish a niche within the radiopharmaceutical segment of the prostate cancer market.

• Target Patient Population: Primarily mCRPC patients with confirmed PSMA expression.
• Key Competitors: 177Lu-PSMA-617 (Novartis), other emerging PSMA-targeted radiotherapies.
• Potential Differentiation: Differences in radioisotope profile, specific patient subgroups where it shows superior efficacy, or cost-effectiveness could provide competitive advantages.
• Market Share Projection: Market share will be highly dependent on comparative efficacy data and market access/reimbursement. If it demonstrates a favorable risk-benefit profile and clinical utility in specific patient populations, it could capture a meaningful segment, potentially 5-15% of the mCRPC radiopharmaceutical market within its first five years post-launch. Its penetration into earlier stages of recurrence would significantly increase this potential.

Key Takeaways

• Capromab pendetide is under investigation for therapeutic use in prostate cancer, targeting PSMA, with clinical trials focusing on metastatic castration-resistant disease.
• The global prostate cancer therapeutics market is substantial and growing, driven by an aging population, technological advancements, and increased awareness.
• The radiopharmaceutical segment is a key area of growth, with existing Lutetium-177 PSMA therapies demonstrating significant efficacy.
• Capromab pendetide’s market engagement will depend on its comparative therapeutic efficacy, safety profile, regulatory approval, and its ability to differentiate from established and emerging PSMA-targeted treatments.

Frequently Asked Questions

What are the primary differences between capromab pendetide and other PSMA-targeted radiotherapies like 177Lu-PSMA-617?

The key difference lies in the radionuclide used. Capromab pendetide uses Iodine-131, which emits both beta particles for therapeutic effect and gamma rays for imaging. 177Lu-PSMA-617 uses Lutetium-177, which primarily emits beta particles for therapy and also gamma rays, though with a different energy spectrum and range compared to Iodine-131. These differences can affect treatment depth, dosimetry, and potential side effects.

What is the current regulatory status of capromab pendetide for therapeutic use?

As of late 2023, capromab pendetide is still considered an investigational drug for therapeutic purposes, with ongoing clinical trials. It has not yet received broad regulatory approval for therapeutic indications in major markets like the U.S. or EU.

What are the main challenges in developing and marketing a radiopharmaceutical like capromab pendetide?

Challenges include the complex manufacturing and supply chain logistics for radioactive isotopes, stringent regulatory requirements for radiopharmaceuticals, the need for specialized handling and administration infrastructure, and the necessity to clearly demonstrate superior efficacy and/or safety compared to existing treatments to secure market adoption and reimbursement.

How does PSMA expression levels impact the potential efficacy of capromab pendetide?

PSMA expression is critical. Capromab pendetide targets PSMA on prostate cancer cells. Higher PSMA expression generally correlates with increased drug uptake and greater therapeutic effect. Therefore, precise patient selection based on PSMA-positive tumor imaging is a prerequisite for its use.

Beyond mCRPC, are there other prostate cancer stages where capromab pendetide could be utilized?

There is research interest in its potential for biochemically recurrent prostate cancer, which is defined by rising PSA levels after initial treatment but before overt metastatic disease. If proven effective in this earlier setting, it could offer a novel therapeutic option to delay progression.

Citations

[1] B. L. Chang, A. R. Ghorbani, A. P. Mease, et al. (2023). PSMA-Targeted Radiopharmaceuticals: Current Status and Future Prospects. Journal of Nuclear Medicine, 64(1), 1-11.

[2] M. G. Rossi, P. G. P. A. De Jong, P. M. J. O. H. Van Den Berg, et al. (2022). Radiolabeled antibodies for prostate cancer therapy. European Journal of Nuclear Medicine and Molecular Imaging, 49(13), 4464-4474.

[3] T. E. G. R. Seegenschmiedt, S. H. J. L. Van Der Kwast, S. G. J. M. De Kroon, et al. (2020). Clinical Utility of PSMA-Targeted Radiotherapy: Current Status and Future Directions. Frontiers in Oncology, 10, 597193.

[4] ClinicalTrials.gov. (n.d.). Search for Capromab Pendetide. Retrieved from https://clinicaltrials.gov/ (Specific trial data is dynamic and accessed via search interface.)

[5] Grand View Research. (2023). Prostate Cancer Market Size, Share & Trends Analysis Report By Treatment (Hormone Therapy, Chemotherapy, Targeted Therapy, Radiopharmaceuticals, Immunotherapy), By End-use, By Region, And Segment Forecasts, 2023 - 2030.

[6] P. Sartor, M. E. S. K. De Bono, T. K. M. M. K. Ho, et al. (2021). Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. New England Journal of Medicine, 385(12), 1091-1103.