Prostate MOlecular Targeting to Enhance surgery using IR800 IAB2M

Phase 1

Suspended

• Conditions: Prostate Cancer; Cancer

• Registration Number: ISRCTN10046036
• Lead Sponsor: niversity of Oxford

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38853153/ (added 16/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-09
• Last Update Posted: 29 July 2024
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: Suspended
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

Current inclusion criteria as of 23/11/2021:

1. Histologically proven intermediate/high-risk untreated PC undergoing radical prostatectomy, where the indication for sparing the neurovascular bundle on either or both sides is equivocal.
2. Suitable for surgery by local standard of care
3. An understanding of the English language sufficient to understand written and verbal information about the trial and its consent process
4. Participant is willing and able to give informed consent for participation in the study.
5. Aged 18 years or above

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Previous inclusion criteria:

1. Men with histologically proven high-risk non-metastatic localized or locally advanced (cT3) PC with any of the following risk criteria:
Risk 1: Serum PSA 10-20ng/ml and Gleason 4+3 or greater
Risk 2: Serum PSA =20 ng/ml
Risk 3: Grade group 4 or 5
Risk 4: Clinical T3
2. Eligible for robot-assisted laparoscopic radical prostatectomy by local standard of care
3. An understanding of the English language sufficient to understand written and verbal information about the trial and its consent process
4. Participant is willing and able to give informed consent for participation in the study
5. Aged 18 years or above

Exclusion Criteria

Current exclusion criteria as of 23/11/2021:

1. Unfit for radical surgery
2. History of any cancer, except non-melanoma skin cancer
3. Presence of metal implants/stents in the urethra
4. Men with renal impairment with a Glomerular Filtration Rate (GFR) of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced Magnetic Resonance Imaging (MRI))
5. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
6. Unable to provide informed consent to participate in the trial as judged by the attending clinician

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Previous exclusion criteria:

1. Unfit for radical surgery as assessed by Consultant Anaesthetist
2. History of any cancer, except non-melanoma skin cancer
3. Men who have had androgen suppression/hormone treatment within the previous 12 months for their PC
4. Men who have had previous High Intensity Focussed Ultrasound (HIFU), cryosurgery, thermal or microwave therapy to the prostate
5. Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within six months. These patients may be included within the trial if deferred from consenting and screening until at least six months following the TURP
6. Presence of metal implants/stents in the urethra
7. Men with renal impairment with a Glomerular Filtration Rate (GFR) of < 35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced Magnetic Resonance Imaging (MRI))
8. Serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
9. Unable to provide informed consent to participate in the trial as judged by the attending clinician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visibility of lesions including autofluorescence; Timepoint(s): At surgery

Secondary Outcome Measures

Name	Time	Method
Stage 1:<br>Adverse events assessment from consent up to 6 weeks post-surgery<br><br>Stage 2:<br>1. Biochemical relapse measured using a Prostate Specific Antigen blood test at 6 weeks post-surgery<br>2. Time to administration of salvage therapy such as external beam irradiation and/or androgen suppression measured by recording the time between intervention and the administration of salvage therapy during follow up routine NHS care in the clinic up to 5 years post-surgery<br>3. Disease specific and overall mortality assessed annually by reviewing medical notes up to five years post-surgery<br>4. Safety measured using adverse events assessment from consent up to 6 weeks post-surgery