OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry. (OSPREY)

OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)

The OSPREY Patient Registry has been developed to collect and assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.

The Registry data will provide both complementary and contemporary information to the existing clinical data across various countries and will form part of the post-market clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only in countries with regulatory (commercial) approval for the OncoSil™ device.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Pancreatic Diseases; Digestive System Neoplasm; Digestive System Disease; Pancreatic Neoplasm; Endocrine Gland Neoplasm

Detailed Description

OSPREY is a post-market, global, multicentre, observational, prospective registry in which data is recorded from patients who undergo OncoSil™ device implantation.

Countries intended for initial commercial distribution include Australia, Belgium, France, Germany, Italy, Singapore, Spain, & the United Kingdom.

Only patients who are intended to undergo treatment with the OncoSil™ device in the commercial (sales) setting will participate in this Registry.

Every patient who is prescribed OncoSil™ in the commercial setting will be approached by the Treating Physician to consent to participate in the OSPREY Patient Registry.

Patients who choose not to consent to participate in the OSPREY Patient Registry will not be excluded from being treated with the OncoSil™ device.

Five hundred patients (implanted with OncoSil™) will be recruited into the OSPREY Patient Registry. It is anticipated recruitment will be over a five-year period, subject to the rate of commercial adoption of the OncoSil™ device in the market.

To adequately collect data relating to the performance and safety of the OncoSil™ device, data will be collected from patients over a prescribed 12-month period from enrolment, the cohort is then followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™.

Therefore, the Registry is expected to run for a seven-year period. Relevant observational data will be collected via medical record review.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Tom Maher; Phone Number: +44 750 4658585; Email: tom.maher@oncosil.com
• Study Contact Backup: Name: Nicole G Gaddi, B.Sc Nursing; Phone Number: + 61 (0)428 946 588; Email: nicole.gaddi@oncosil.com

Study Locations

• Spain
  • Las Palmas De Gran Canaria, Spain
    • Recruiting
    • Complejo Hospitalario Universitario Insular Materno-Infantil
    • Contact: Fayna Armas, MD
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon Y Cajal
    • Contact: Ana Garcia, MD
  • Madrid, Spain, 28942
    • Recruiting
    • Hospital Universitario de Fuenlabrada
    • Contact: Fernando Pereira, MD
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Universitario Doce De Octobre
    • Contact: Maria J Tabuenca, MD
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Universitario La Paz
    • Contact: Eva Martin, MD
  • Pamplona, Spain
    • Recruiting
    • Clínica Universidad de Navarra
    • Contact: Maria M Rodriguez, MD
  • Valladolid, Spain
    • Recruiting
    • Hospital Clínico Universitario de Valladolid
    • Contact: Purificacion Rodriguez, MD
• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • Hammersmith Hospital
    • Contact: Harpreet Wasan, MD
  • London, United Kingdom
    • Not yet recruiting
    • The London Clinic
    • Contact: Zarni Win

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Every patient who is intended to undergo implantation of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, in the commercial (sales) setting will be approached by the Treating Physician to consent to participate in the OSPREY Patient Registry.

Patients who choose not to consent to participate in the OSPREY Patient Registry will not be excluded from being treated with the OncoSil™ device.

.

Description

Inclusion Criteria:

1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.
3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
4. Pancreatic target tumour recommended size of <7 cm (longest diameter) and <110 cc volume.
5. A clinically acceptable ECOG performance status.
6. Patients ≥ 18 years of age at screening.
7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.
8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.

Exclusion Criteria:

1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
3. Evidence of distant metastases based on review of baseline CT scan.
4. More than one primary lesion.

5. In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:

   • where previous EUS-FNA was considered technically too difficult to perform;
   • imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
   • presence (or significant risk) of varices near to the target tumour.
6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended.
8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.
9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of Device	The analysis for safety within the real-world setting will be performed. The safety of OncoSil™ is defined by the Adverse Event profile. All safety summaries will be produced for the Intention-To-Treat (ITT) population. Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Events recorded during the Registry will be listed. Summary tables will be produced for Treatment Emergent Adverse Events (TEAEs). The number and percentage of patients with device-related Adverse Events by system organ class (SOC) and preferred term will be tabulated. Similar summaries will be produced by severity of event (both mild, moderate or severe, CTCAE grade 1-4) and drug and/or device relationship. In addition, summary tables will be produced for serious TEAEs and TEAEs associated with special interest acute/late radiation effects and or withdrawal.	Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
Device Implantation Performance	Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. An assessment of the utility of OncoSil™ Implantation will be made and listed appropriately.	7 years
Overall Survival	Overall survival (OS) is defined as the time from enrolment to the date of death from any cause. Patients who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the patient was known to be alive. Overall Survival (OS) will be analysed at the interim analysis and once all 500 OncoSil™ implanted patients have been followed to death or to 24-months post the date of the last enrolled/treated patient.	Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1	Target (implanted) tumor response (local and distant)	7 years
Resection Rates	Surgical resection rates and outcome	7 years

Collaborators and Investigators

• Sponsor: OncoSil Medical Limited
• Investigators: Principal Investigator: Paul J Ross, MRCP, MBBS, Guy's and St Thomas' NHS Foundation Trust, London, UK

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Gemcitabine; Pancreatic Cancer; Unresectable; Pancreas; Device; Brachytherapy; Abraxane; Metastases; Pancreatic tumor; Locally advanced; Implantable; Radiographic; Phosphorous-32; OncoSil™; Nab-paclitaxel
• Additional Relevant MeSH Terms: Neoplasms; Pancreatic Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Endocrine System Diseases; Pancreatic Diseases; Neoplasms by Site; Endocrine Gland Neoplasms
• Other Study ID Numbers: OSPREY01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No