Source Paper
Ardeshir R. Rastinehad, Harry Anastos, Ethan Wajswol, Jared S. Winoker, John P. Sfakianos et al.
Proceedings of the National Academy of Sciences • 2019
Significance Prostate cancer is the most common nonskin cancer in the United States, where approximately 1 in 9 men will be diagnosed in their lifetime. The prostate is near several vital structures, such as the urethra and neurovascular bundle, and whole gland treatments for prostate cancer can disrupt normal urinary, bowel, and sexual functioning. Here we report the initial results of a clinical trial for nanoparticle-based photothermal cancer therapy. The trial was designed to perform ultrafocal photothermal ablation of cancerous tumors within the prostate. Gold-silica nanoparticles designed to absorb near-infrared light at wavelengths of high tissue transparency provide a highly localized light-based strategy for the treatment of prostate cancer, with substantially reduced risks for deleterious treatment-related side effects.
Objective: Longitudinal follow-up assessment of patients at 1, 3, 6, and 12 months postablation to measure adverse events, IPSS/SHIM scores, PSA levels, and liver function
This is a Clinical Follow-up Assessment protocol using human as the model organism. The procedure involves 22 procedural steps, 9 equipment items, 5 materials. Extracted from a 2019 paper published in Proceedings of the National Academy of Sciences.
Model and subjects
human • male • 58 to 79 years • 16
Study window
~144.2 hours hands-on
Core workflow
Patient screening and enrollment • Diagnostic imaging and biopsy • Multiparametric MRI acquisition
Primary readouts
Key equipment and reagents
Verified items
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Sixteen men aged 58-79 years with clinical stage T2a or less prostate cancer and Gleason score 4+3 or less were enrolled with minimum 12-month postablation follow-up
“Sixteen men aged 58 to 79 y with clinical stage T2a or less prostate cancer, Gleason score of 4+3 or less, and a minimum postablation follow-up of 12-mo endpoints were analyzed”
All patients diagnosed by MR-US fusion biopsy including targeted and systematic sampling (minimum 12 cores). Patients had discrete MR-visible lesions without other foci of prostate cancer
“All patients were diagnosed by MR-US fusion biopsy, including both targeted and systematic sampling, and had discrete MR-visible lesions without other foci of prostate cancer”
mpMRI obtained using 3-Tesla phased array coil and classified using PI-RADS v2. GSN-mediated laser ablation performed within 4 months of mpMRI acquisition
“mpMRI was obtained using a 3-Tesla phased array coil and classified using the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2). GSN-mediated laser ablation was performed within 4 mo of mpMRI acquisition”
Regions of interest corresponding to lesions detected on prior MR/US fusion biopsy marked using DynaCAD software. 8-10 mm margin of ablation marked around target lesion while avoiding critical structures
“Regions of interest corresponding to the lesions detected on prior MR/US fusion biopsy were marked in preparation for GSN-mediated laser ablation. Region of interest selection and prostatic segmentation were performed, using DynaCAD software (InVivo, A Philips Healthcare Company, Best, Netherlands). An 8- to 10-mm margin of ablation around the target lesion or lesions was marked while avoiding critical nearby structures”
Trocar/laser fiber placement planned using in-house-generated mockup of transperineal stepper overlaid on ablation and tumor regions. Trocar/laser fiber insertion sites placed 5-7 mm apart considering 4-5 mm treatment radius around optical fiber diffuser
“Stereotactic trocar/laser fiber placement was planned, using an in-house-generated mockup of a transperineal stepper overlaid on the ablation and tumor regions of interest. To ensure complete coverage of the lesion(s), trocar/laser fiber insertion sites were placed ≈5 to 7 mm apart, considering a 4- to 5-mm treatment radius around the optical fiber diffuser”
Patients received 7.5 mL/kg i.v. infusion of GSN (4.8 mg/mL) through standard nonbis(2-ethylhexyl) phthalate infusion set at rate of 120-600 mL/h
“On treatment day 1, patients received a 7.5 mL/kg i.v. infusion of GSN (4.8 mg/mL) through a standard nonbis(2-ethylhexyl) phthalate infusion set at a rate of 120 to 600 mL/h”
Before treatment on day 2, patients received saline enema and single dose of Gentamicin 160 mg i.v.
“Before treatment on day 2, patients received a saline enema and single dose of Gentamicin 160 mg i.v. PB”
Patients underwent laser illumination under general anesthesia while positioned in dorsal lithotomy position
“Patients subsequently underwent laser illumination under general anesthesia while positioned in the dorsal lithotomy position”
Periprostatic nerve block performed using 1% lidocaine without epinephrine under transrectal ultrasound guidance via the perineum
“Periprostatic nerve block was performed using 1% lidocaine without epinephrine under transrectal ultrasound guidance via the perineum”
Multiple 14-gauge needle-guided introducers placed transperineally using BK ultrasound 8848 probe, CIVCO 14-gauge grid, and UroNav MR/US fusion guidance platform with EM compatible stepper
“In conjunction with a biplanar BK ultrasound 8848 probe, 14-gauge grid (CIVCO 610–977), and an EM-tracked MR/US fusion guidance platform with EM compatible stepper (UroNav, A Philips Healthcare company, Best, Netherlands), multiple 14G needle-guided introducers were placed transperineally”
Trocars removed just before laser catheter inserted sequentially into each trocar cannula. Near-infrared light (810±10 nm) delivered continuously for 3 minutes at subablative power level in absence of GSN
“Once all introducers were in place, the trocars were removed just before the laser catheter was inserted sequentially into each trocar cannula, and near-infrared light (810 ± 10 nm) was delivered continuously for 3 min at a power level subablative in the absence of GSN”
Consecutive laser activations performed after withdrawing laser fiber to allow adequate coverage of intended ablation zone. 8-mm withdrawal used for 10-mm OFD, 12-mm withdrawal for 18-mm OFD
“Depending on the cranio-caudal dimension of the intended ablation zone, consecutive laser activations took place after withdrawing the laser fiber, to allow for adequate coverage of the intended ablation zone. An 8-mm withdrawal was used for the 10-mm OFD, and 12-mm withdrawal for the 18-mm OFD”
Needle thermocouples placed near critical structures (urethra, urinary sphincter, rectal wall) when intended ablation zone in close proximity to monitor and minimize tissue damage risk
“To monitor and minimize the risk for tissue damage near critical structures, needle thermocouples were placed near them when the intended ablation zone was in close proximity”
Single 3-minute continuous laser excitation with same laser power performed at location contralateral to target lesion to evaluate whether ablation occurred in absence of GSN
“As a control treatment, a single 3-min continuous laser excitation with the same laser power was performed at a location contralateral to the target lesion to evaluate whether or not ablation occurred in the absence of GSN”
Patients discharged on same day of procedure after several hours of monitoring and successful voiding trial
“Patients were discharged on the same day of the procedure after several hours of monitoring and a successful voiding trial”
Subjects underwent mpMRI to evaluate radiologic treatment response at planned ablation zone
“At 48 to 72 h posttreatment, subjects underwent mpMRI to evaluate the radiologic treatment response at the planned ablation zone”
History and physical performed to document potential adverse events. IPSS and SHIM scores, PSA, and liver function tests documented
“Posttreatment follow-up was performed at 1, 3, 6, and 12 mo postablation. At each visit, a history and physical were performed to document any potential adverse events; in addition, patient IPSS and SHIM scores, PSA, and liver function tests were documented”
History and physical performed. IPSS and SHIM scores, PSA, and liver function tests documented. Repeat mpMRI and MR/US targeted biopsy performed
“At 3 and 12 mo, patients underwent repeat mpMRI and MR/US targeted biopsy, along with a 12-core systematic biopsy at 12 mo”
History and physical performed to document potential adverse events. IPSS and SHIM scores, PSA, and liver function tests documented
“Posttreatment follow-up was performed at 1, 3, 6, and 12 mo postablation. At each visit, a history and physical were performed to document any potential adverse events; in addition, patient IPSS and SHIM scores, PSA, and liver function tests were documented”
History and physical performed. IPSS and SHIM scores, PSA, and liver function tests documented. Repeat mpMRI, MR/US targeted biopsy, and 12-core systematic biopsy performed
“At 3 and 12 mo, patients underwent repeat mpMRI and MR/US targeted biopsy, along with a 12-core systematic biopsy at 12 mo”
Biopsy by mass (6.3±5.8 mg) taken from treatment zone to document presence of nanoshells within treated tumor. Elemental analysis performed using Nuclear Activation Analysis
“First, the 6.3 ± 5.8 mg biopsy by mass was taken from the treatment zone to document the presence of nanoshells within each treated tumor. An elemental analysis was performed on each biopsy core, using Nuclear Activation Analysis”
48-72 hour posttreatment DCE MRI compared with minimal thermal ablation zone generated by control treatment to confirm applied laser dose was specific to tissues containing nanoshells
“Second, the 48- to 72-h posttreatment DCE MRI helped to establish the volume of target tissue damage before necrotic reformation. This was compared with the minimal thermal ablation zone generated by the control treatment duplicating the laser dose in each patient, and was taken as confirmation that the applied laser dose was specific to tissues containing nanoshells”
This section explains what the experiment is doing, which readouts matter, what the data artifacts usually look like, and how the analysis should flow from raw capture to reported result.
Longitudinal follow-up assessment of patients at 1, 3, 6, and 12 months postablation to measure adverse events, IPSS/SHIM scores, PSA levels, and liver function
Objective
Longitudinal follow-up assessment of patients at 1, 3, 6, and 12 months postablation to measure adverse events, IPSS/SHIM scores, PSA levels, and liver function
Subjects
From paperhuman • male • 58 to 79 years
Sample count
From paper16
Cohort notes
From paperPatients with clinical stage T2a or less prostate cancer, Gleason score of 4+3 or less, with minimum postablation follow-up of 12 months
Patient screening and enrollment
Diagnostic imaging and biopsy
Multiparametric MRI acquisition (Within 4 months of mpMRI)
Treatment planning with DynaCAD
Adverse events documentation
From paperElemental analysis performed on biopsy cores using Nuclear Activation Analysis to document nanoshell presence.
Artifact type
Representative image panels with region or marker comparisons
Comparison focus
Compare staining intensity, structure, or cell counts across matched conditions
IPSS (International Prostate Symptom Score) scores
From paperElemental analysis performed on biopsy cores using Nuclear Activation Analysis to document nanoshell presence.
Artifact type
Representative image panels with region or marker comparisons
Comparison focus
Compare staining intensity, structure, or cell counts across matched conditions
SHIM (Sexual Health Inventory for Men) scores
From paperElemental analysis performed on biopsy cores using Nuclear Activation Analysis to document nanoshell presence.
Artifact type
Representative image panels with region or marker comparisons
Comparison focus
Compare staining intensity, structure, or cell counts across matched conditions
PSA (Prostate-Specific Antigen) levels
From paperElemental analysis performed on biopsy cores using Nuclear Activation Analysis to document nanoshell presence.
Artifact type
Representative image panels with region or marker comparisons
Comparison focus
Compare staining intensity, structure, or cell counts across matched conditions
Adverse events documentation
From paperRaw artifact
Field or section images captured from matched samples
Processed artifact
Selected representative panels with quantified intensity, counts, or area measurements
Final reported form
Per-group imaging summaries with representative figures and quantified endpoints
IPSS (International Prostate Symptom Score) scores
From paperRaw artifact
Field or section images captured from matched samples
Processed artifact
Selected representative panels with quantified intensity, counts, or area measurements
Final reported form
Per-group imaging summaries with representative figures and quantified endpoints
SHIM (Sexual Health Inventory for Men) scores
From paperRaw artifact
Field or section images captured from matched samples
Processed artifact
Selected representative panels with quantified intensity, counts, or area measurements
Final reported form
Per-group imaging summaries with representative figures and quantified endpoints
PSA (Prostate-Specific Antigen) levels
From paperRaw artifact
Field or section images captured from matched samples
Processed artifact
Selected representative panels with quantified intensity, counts, or area measurements
Final reported form
Per-group imaging summaries with representative figures and quantified endpoints
Acquisition
Collect raw experimental outputs with enough metadata to preserve sample identity, condition, and timing.
Preprocessing / cleaning
Elemental analysis performed on biopsy cores using Nuclear Activation Analysis to document nanoshell presence.
Scoring or quantification
Quantify the primary readouts for this experiment: Adverse events documentation; IPSS (International Prostate Symptom Score) scores; SHIM (Sexual Health Inventory for Men) scores; PSA (Prostate-Specific Antigen) levels.
Statistical comparison
Statistical method not yet structured for this page.
Reporting output
Report representative outputs alongside summary comparisons for Adverse events documentation, IPSS (International Prostate Symptom Score) scores, SHIM (Sexual Health Inventory for Men) scores, PSA (Prostate-Specific Antigen) levels.
Source links and direct wording from the methods section for validation and deeper review.
Citation
Ardeshir R. Rastinehad et al. (2019). Gold nanoshell-localized photothermal ablation of prostate tumors in a clinical pilot device study. Proceedings of the National Academy of Sciences
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InVivo, A Philips Healthcare Company, Best, Netherlands
Philips Healthcare Company, Best, Netherlands
BK • 8848
CIVCO • 610-977
Nanospectra Biosciences, Inc., Houston, TX
Nanospectra Biosciences, Inc.
InVivo, A Philips Healthcare Company
2 items with ReplicateScience direct pages
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22
Evidence Quotes
36
Protocol Items
14
Linked Products
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Steps
22
Evidence
36
Specific Products
2/2
Canonical Sync
Pending
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Computed from the current experiment record updated Feb 28, 2026.
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