The Prostate Cancer Clinical Trials Consortium

What The Prostate Cancer Clinical Trials Consortium does

The Prostate Cancer Clinical Trials Consortium (PCCTC) is an integrated research organization (IRO) and global academic clinical consortium that operates as a specialized, disease-focused contract research organization (CRO) for prostate cancer drug and biomarker development. Founded in 2005 by the Prostate Cancer Foundation and the U.S. Department of Defense Prostate Cancer Research Program, the PCCTC was established as an independent LLC in 2014 with Memorial Sloan Kettering Cancer Center (MSK) as its sole member. Headquartered in New York, the consortium manages a network of over 200 global clinical research sites spanning academic medical centers, community hospitals, and research institutions across the US and 15+ countries. Its Scientific Oversight Committee comprises internationally recognized prostate cancer investigators from leading US academic medical centers, and the consortium's investigators developed the universally adopted clinical states model of prostate cancer and lead the Prostate Cancer Working Group (PCWG2, PCWG3, PCWG4) frameworks that define global standards for prostate cancer clinical trial design.

The PCCTC's core technology stack includes Medidata Rave for EDC, CDISC-conformant CRF libraries mapped to SDTM/ADaM, integrated data review processes with cross-functional checkpoints, centralized medical dictionary management (MedDRA, WHO Drug, LOINC/SNOMED), and a Data Science team using R programming with GitHub-based version control. Correlative science capabilities include CLIA-certified and CAP-accredited laboratory integrations, computational biology, and molecular pathology. The consortium's service portfolio spans Clinical Operations, Regulatory Affairs, Clinical Data Management, Statistical Programming and Analysis, Data Science, Correlative Science and Laboratory Services, Quality Assurance, Advisory Board facilitation, Medical Communications, and Contracts/Budgeting — offered under both full-service CRO and functional service provider (FSP) engagement models.

The PCCTC generates revenue through three primary streams: industry-sponsored contract research services from biopharmaceutical companies (Pfizer, AstraZeneca, Bristol-Myers Squibb, Sanofi-Genzyme, plus emerging biotechs such as K36 Therapeutics, CellCentric, and OncoC4); NIH-sponsored and government-funded research including DOD Prostate Cancer Research Program grants and registries such as IRONMAN (NCT03151629) and PROMISE (NCT04995198); and philanthropic contributions from organizations such as the Prostate Cancer Foundation, American Cancer Society, and Friends and Family Against Prostate Cancer. Pricing is negotiated contractually per study with no public fee schedules. To date, PCCTC investigator-led studies have contributed to 27 therapeutic candidates advancing to Phase 3, nine of which are FDA-approved, with 17,800+ participants enrolled across 334 studies and over 547 abstracts and 207 peer-reviewed publications produced.

Name

The Prostate Cancer Clinical Trials Consortium

Legal name

Prostate Cancer Clinical Trials Consortium, LLC

Website

https://pcctc.org

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

The Prostate Cancer Clinical Trials Consortium is an integrated research organization and global academic clinical consortium providing specialized CRO services exclusively for prostate cancer drug and biomarker development, serving biopharmaceutical sponsors, academic medical centers, and government agencies through a network of over 200 global clinical research sites.

Ownership category

akta.pro rank

Product category

Contract Research Organization Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA)

akta.pro secondary industries

Data Management, Biostatistics & Statistical Programming FSP (HLAGAOAB), Medical Writing & Clinical Documentation FSP (HLAGAOAC), Clinical Trial Supply, Logistics & Vendor Management FSP (HLAGAOAH)

Keywords

• Clinical research organization
• Oncology clinical trials
• Prostate cancer research
• Contract research services
• Biopharmaceutical trial management

Headquarters

HQ city

New City

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Supply Chain

Revenue model

1. Industry-Sponsored Clinical Research Services: The PCCTC offers full-service study management and functional service provider (FSP) project support to biopharmaceutical companies conducting prostate cancer clinical trials. Revenue is generated through negotiated contracts with industry partners for clinical research activities, including project management, regulatory affairs, data management, statistical programming, correlative science, and medical communications services.
2. NIH-Sponsored and Foundation Research: The PCCTC manages clinical studies funded by the U.S. Department of Defense Prostate Cancer Research Program (PCRP) and other NIH-sponsored trials, including registries such as IRONMAN and PROMISE. Revenue derives from research grants and cooperative agreement funding.
3. Philanthropic Contributions: The PCCTC receives philanthropic investments from organizations such as Friends and Family Against Prostate Cancer to support specific infrastructure and research enhancements, including biomarker studies embedded within clinical trials.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels6 records

Core offering

The PCCTC is an integrated research organization (IRO) and global clinical consortium providing full-service contract research organization (CRO) and functional service provider (FSP) support exclusively for prostate cancer clinical trials. Its services include study/project management, regulatory affairs, clinical data management, statistical programming, data science, correlative science and laboratory services, quality assurance, advisory board facilitation, and medical communications, executed across a network of over 200 global clinical research sites.

Product overview

The PCCTC is an integrated research organization (IRO) and multicenter Contract Research Organization (CRO) that offers a comprehensive suite of clinical research services for prostate cancer drug development. The organization provides services spanning the entire clinical trial lifecycle including Clinical Operations (project management, site coordination), Regulatory Affairs, Clinical Data Management (using Medidata Rave), Statistical Programming and Analysis, Data Science, Correlative Science and Laboratory Services, Quality Assurance, Advisory Board facilitation, Medical Communications, and Contracts/Budgeting. The PCCTC also manages major clinical registries including the IRONMAN Registry (international prostate cancer registry), PROMISE Registry (germline mutations registry), and conducts proprietary studies such as the TALENT study. Through the Prostate Cancer Working Group (PCWG2/3/4), the organization establishes clinical trial design standards for the broader prostate cancer research community. The consortium operates as a network of over 200 global clinical research sites spanning academic medical centers, community hospitals, and research institutions across the US and internationally.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Operations Services Comprehensive study management from concept to close-out, with project management and site coordination ensuring studies are completed on time and on budget and facilitating efficient collaboration between industry partners, investigators, and participating sites across the PCCTC's 200+ global clinical research site network.
• Regulatory Affairs Services Regulatory expertise, guidance, and ongoing oversight to ensure that activities throughout the lifecycle of a clinical study meet evolving regulatory requirements, coordinating document management across projects for prostate cancer clinical trials.
• Clinical Data Management Modern, standards-driven clinical data management using Medidata Rave (EDC) functionality and CDISC-conformant libraries to deliver secure, high-quality data management for prostate cancer clinical trials.
• Statistical Programming and Analysis Biostatistics and statistical programming services involved in all stages of clinical study planning and execution, including protocol development, data collection design, ongoing data quality monitoring, and regular reporting checkpoints for prostate cancer clinical trials.
• Data Science Services Clinical data science covering development of statistical models, custom data delivery and reporting pipelines, and rigorous analysis and validation of datasets in collaboration with Memorial Sloan Kettering Cancer Center.
• Correlative Science and Laboratory Services Laboratory capabilities meeting the demands of drug development through partnerships with CLIA-certified and CAP-accredited laboratories offering consulting, analytical services, specimen processing, storage, and tracking.
• Quality Assurance Services Comprehensive SOPs and project-specific management plans ensuring the conduct of meaningful quality assurance audits internally, with external vendors, and with participating sites for prostate cancer clinical trials.
• Advisory Board Services Access to the nation's leading prostate cancer investigators for advisory boards enhancing protocol design, endpoint selection, and patient population decisions for industry-sponsored clinical trials.
• Medical Communications Services Medical writing and editorial services including protocol development, informed consent forms, study presentations, abstracts, peer-reviewed manuscripts, and regulatory documentation.
• Contracts and Budgeting Services Suite of budgeting and contracting tools including confidentiality disclosure agreements, master clinical trial agreements, and negotiation services to expedite study activation across the consortium's site network.

Quantifiable outcome

• 27 therapeutic candidates advanced to Phase 3; 9 FDA-approved therapies
• +5 more outcomes

Named customers16 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

15 partnerships are on record, tiered core, major, supporting, strategic and founding.

• PfizercoreStrategic or Co-development Partner · 1 January 2025Pfizer is the funder and industry partner for the TALENT study (NCT06844383), a PCCTC-managed randomized Phase 2 trial evaluating talazoparib with or without enzalutamide in mCRPC patients with HRR mutations after progression on abiraterone acetate.
• American Cancer SocietymajorStrategic or Co-development Partner · 9 July 2024American Cancer Society collaboration with Trial Library and PCCTC to support a national initiative to accelerate recruitment of Black patients to prostate cancer clinical trials. ACS provides up to $200,000 per year for two years to community oncology practices, paired with Trial Library's patient identification platform and PCCTC's hypothesis-driven trial network.
• Trial Library, Inc.majorStrategic or Co-development Partner · 1 January 2024Trial Library partners with PCCTC to enroll hundreds of patients with prostate cancer into clinical trials across the U.S. Trial Library provides patient identification and navigation support through software and technology-enabled services integrated in community practices. Previously partnered to enroll patients on hypothesis-driven trials.
• K36 TherapeuticscoreStrategic or Co-development Partner · 1 January 2024K36 Therapeutics engaged PCCTC to manage the STRIKE-001 phase 1 clinical trial (NCT07103018) evaluating KTX-2001, a novel NSD2 inhibitor, alone and in combination with darolutamide in participants with mCRPC. PCCTC provided rapid regulatory submission to site initiation, demonstrating operational excellence.
• AstraZenecacoreStrategic or Co-development Partner · 1 January 2024AstraZeneca funded the landmark BRCAAway phase 2 trial (NCT03012321) evaluating abiraterone + olaparib in first-line mCRPC with DNA repair defects, conducted across 15 leading cancer centers and managed by PCCTC.
• Sanofi-GenzymecoreStrategic or Co-development Partner · 1 January 2024Sanofi-Genzyme supported the CASCARA phase 2 trial (NCT03934840) evaluating quadruplet therapy (cabazitaxel, carboplatin, abiraterone, ADT) in high-volume metastatic APMN prostate cancer. The trial was managed by PCCTC.
• Bristol-Myers-SquibbcoreStrategic or Co-development Partner · 1 January 2024Bristol-Myers-Squibb funded the CHAMP phase 2 trial (NCT04709276) evaluating cabazitaxel, carboplatin, ipilimumab, and nivolumab in metastatic neuroendocrine/aggressive variant prostate cancer (NEPC/AVPC), conducted through PCCTC.
• Your Prostate Cancer. HelpsupportingStrategic or Co-development Partner · 1 January 2024Patient advocacy resource supported by PCCTC to support patient recruitment and engagement for clinical trials, aligning with the consortium's mission to translate scientific discoveries to improved standards of care.
• Caris Life SciencesstrategicTechnology or Integration · 2 June 2022Strategic collaboration to guide more precise treatment decisions for patients with advanced prostate cancer. Caris Life Sciences provides comprehensive genomic profiling capabilities integrated with PCCTC's clinical trial infrastructure for precision medicine development.
• Sorrento TherapeuticsstrategicStrategic or Co-development Partner · 2 June 2022Collaboration with Caris Life Sciences and PCCTC to advance precision medicine in prostate cancer using comprehensive genomic profiling, guiding treatment decisions and clinical trial enrollment.
• Lantheus Holdings, Inc. (EXINI Diagnostics AB)strategicTechnology or Integration · 27 January 2022Lantheus subsidiary EXINI Diagnostics AB entered a collaboration with PCCTC to advance AI-enabled imaging biomarkers in prostate cancer. This collaboration leverages PCCTC's clinical trial infrastructure with EXINI's AI-based medical software for imaging analysis.
• OncoC4coreStrategic or Co-development Partner · 1 January 2022OncoC4 engaged PCCTC to manage a Phase 1/2 trial of BNT316/ONC-392 (gotistobart), an anti-CTLA-4 antibody candidate, in combination with radioligand therapy (177Lu-PSMA-617/Pluvicto) for advanced prostate cancer.
• CellCentriccoreStrategic or Co-development Partner · 7 April 2020CellCentric signed an agreement with PCCTC to help select and manage US sites for the ongoing evaluation of CCS1477 (a p300/CBP bromodomain inhibitor) in a Phase II clinical trial expansion into the US market.
• Memorial Sloan Kettering Cancer Center (MSK)coreStrategic or Co-development Partner · 1 January 2014PCCTC, LLC is a single-member limited liability corporation with Memorial Sloan Kettering Cancer Center as the sole member. MSK provides operational infrastructure, affiliation, and hosts the Data Science team in close collaboration with its Biostatistics Service. Key PCCTC leaders (Charles J. Ryan, MD, Medical Director; Michael J. Morris, MD, SOC Chair) are affiliated with MSK. Contact email [email protected].
• Prostate Cancer Foundation (PCF)foundingStrategic or Co-development Partner · 1 January 2005The PCCTC was initiated in 2005 by the Prostate Cancer Foundation (PCF) and the U.S. Department of Defense (DOD) Prostate Cancer Research Program (PCRP) in response to critically unmet needs in prostate cancer clinical research identified by physician investigators and patient advocates. PCF was the founding co-sponsor.

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Medpace Holdings: Medpace is a mid-to-large CRO with notable oncology depth and an operating model that competes with academic consortiums. Sponsors considering PCCTC may also evaluate Medpace for full-service or FSP prostate cancer work.
• ICON plc: ICON is a large global CRO with significant oncology and FSP operations. Sponsors evaluating PCCTC for prostate cancer FSP engagements typically benchmark pricing and capabilities against ICON's broader-scale offerings.
• Parexel International: Parexel is a global CRO with a strong oncology franchise and biopharma sponsor relationships. It is relevant as a competitor for industry-sponsored prostate cancer trials where sponsors want global full-service delivery.
• Labcorp Drug Development (including Covance): Labcorp Drug Development is a global CRO with central laboratory, FSP, and full-service oncology capabilities. It is a comparable peer for biopharma sponsors seeking bundled clinical research services across therapeutic areas including prostate cancer.
• IQVIA: IQVIA is the world's largest CRO offering full-service and FSP clinical research across all major therapeutic areas including oncology. It competes with PCCTC for industry-sponsored oncology trials but operates a much broader portfolio and far larger central team.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-size global CRO with oncology and rare disease depth. It is comparable as a mid-scale oncology CRO competing for industry-sponsored trials where PCCTC is also considered.
• PPD (Thermo Fisher Scientific): PPD, now part of Thermo Fisher, is a global CRO with oncology and biomarker services. It overlaps with PCCTC on industry-sponsored multicenter oncology trials and competes for similar biopharma budgets.

Others

• NCI National Clinical Trials Network (NCTN): NCTN is the US National Cancer Institute's network of cooperative groups that run investigator-led cancer trials. It is adjacent to PCCTC's academic consortium model and partially overlaps on government-funded prostate cancer studies.
• ECOG-ACRIN Cancer Research Group: ECOG-ACRIN is one of the NCTN cooperative groups running NCI-funded cancer clinical trials, including in prostate cancer. It overlaps with PCCTC on academic investigator engagement and government-sponsored prostate cancer trial execution.

Direct peers

• Translational Research in Oncology (TRIO): TRIO is an academic-style oncology CRO that runs global clinical trials with academic investigators in solid tumors including breast cancer. It is a direct peer as an academic-consortium model mirroring PCCTC's investigator-driven, full-service oncology approach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/prostate-cancer-clinical-trials-consortium-pcctc
• Xx.com/thepcctc

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about The Prostate Cancer Clinical Trials Consortium