Across 121 CTIS prostate cancer Phase II/III trial records authorized in 2024–2026, CROs or CRO-like vendors are listed in 61/121 trials (50.4%). CRO use is most concentrated in operationally complex studies: 30/34 trials with 7+ countries (88.2%) and 26/34 trials with 31+ sites (76.5%), while Parexel and ICON group are the most active CRO organizations at 21 CRO-supported trials each.
Among 61 CRO-supported trials, Parexel and ICON group each appear in 21 trials (34.4% of CRO-supported trials). Signant/ERT and IQVIA each appear in 15 trials (24.6%), followed by Syneos Health in 13 trials (21.3%).
The active CRO set is mixed: global CROs dominate full trial operations and CTIS-support roles, while specialized vendors such as Signant/ERT, Bioclinica, Clario, Almac, Labcorp and Medidata concentrate around eCOA, imaging, lab, IRT and supply-chain execution.
CROs are listed in 30/59 Phase II trials (50.8%) and 31/62 Phase III trials (50.0%). By CTIS authorization year, the CRO share is 52.0% in 2024, 48.6% in 2025, and 44.4% in 2026.
Phase alone is not the strongest outsourcing signal. CRO use is stable around one in two trials; operational footprint, sponsor type and CTIS geography explain the sharper differences.
CRO use is lowest in one-country studies at 3/42 trials (7.1%) and highest in 7+ country studies at 30/34 trials (88.2%). The same pattern appears by site count: 2/26 trials with 1–5 sites use CROs (7.7%), compared with 26/34 trials with 31+ sites (76.5%).
For prostate cancer sponsors, the strongest CRO trigger is not patient count alone. The operational inflection point is EU/EEA coordination: CRO-supported trials have a median of 6 countries and 26.5 sites, compared with 1 country and 10 sites in trials without CROs.
Metastatic castration-resistant prostate cancer (mCRPC) accounts for 46 trials, with CROs used in 33/46 (71.7%). Basket or prostate-including solid tumor trials have the highest disease-complexity rate at 8/11 (72.7%), while trials with 4+ disease labels show CRO use in 8/10 records (80.0%).
mCRPC and basket studies create the strongest outsourcing signal because they combine competitive oncology recruitment, biomarker or imaging needs, and broader CTIS country operations. ADC and bispecific antibody trials also show high CRO use, at 6/7 (85.7%) and 4/5 (80.0%) respectively.
The most frequent outsourced function category is central lab, biomarker or pharmacokinetic (PK) work, present in 46/121 trials (38.0%). Clinical operations or site support appears in 43/121 trials (35.5%), followed by eCOA/ePRO/diary/data-capture services in 35/121 (28.9%) and imaging/BICR/dosimetry in 33/121 (27.3%).
The outsourcing mix is highly operational rather than purely regulatory. Prostate cancer trials most often outsource specialized evidence-generation infrastructure: central labs, biomarker/PK work, imaging review, eCOA/ePRO, IRT, and IP logistics.
Spain appears in 51 CRO-supported country entries, France in 49, Germany in 38, Italy in 37 and Poland in 30. CRO-supported trials also have longer trial-level CTIS submission-to-first-authorization timelines, with a median of 90 days versus 43.5 days without CROs.
For CTIS and EU submission planning, the CRO decision is strongly linked to cross-country coordination. Sponsors planning Spain, France, Germany, Italy and Poland in the same prostate cancer program should expect CRO support to be common, especially when country additions, site activation, translation, imaging, lab and data workflows run in parallel.
Pharmaceutical-company sponsors account for 74/121 trials and use CROs in 60/74 records (81.1%). Hospital or clinic sponsors account for 29/121 trials and list CROs in 0/29 records (0.0%), despite often running country-specific prostate cancer studies.
The commercial CRO opportunity is concentrated in pharma-led prostate cancer development, especially global or US/European sponsor programs entering CTIS with multi-country Phase II/III designs. Investigator-led and institution-led trials appear more likely to rely on internal networks or cooperative groups.
CRO selection is most justified when a prostate cancer Phase II/III study crosses CTIS complexity thresholds: 7+ countries, 31+ sites, mCRPC or basket disease scope, and specialized operational functions such as central lab, imaging/BICR, eCOA/ePRO, IRT and drug-supply logistics.