Prostate CancerPhase 2NCT04221828
Trial of NanoPac Focal Therapy for Prostate Cancer
A Phase 2 study testing NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension in people with Prostate Cancer and Prostate Adenocarcinoma, run by NanOlogy, LLC at 4 sites in United States.
Trial summary
This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Adenocarcinoma
- What is being tested?
- NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Oct 2020to 8 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age;
- Histopathologically proven adenocarcinoma of the prostate:
- Localized cancer;
- Subjects with tumors classified as <T3 per TNM classification, Gleason score≥ 6;
- Prostate tumor must be able to be visualized on mpMRI;
- Already considered to be candidate for radical prostatectomy;
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- Considered appropriate for treatment with paclitaxel therapy;
- Laboratory requirements:
- WBC >2500/mm3
- Neutrophil >1500/mm3
- Hemoglobin >10 mg/dL
- Platelet >100,000/ mm3
- AST and ALT <2.5 x ULN
- Total bilirubin <1.5 x ULN
- Calculated creatinine clearance ≥ 30 ml/min
- Normal PT/INR and PTT;
- ECOG of 0 or 1;
- International Prostate Symptom Score (I-PSS) less than or equal to 20;
- If sexually active, willing to use double condoms from time of NanoPac injection until prostatectomy;
- Agree to all study procedures and provide signed informed consent;
Who cannot join
- Evidence of locally advanced or metastatic disease;
- Prostate size ≥ 50 cc;
- Prior prostatectomy, including surgery for any benign condition (such as TURP);
- Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) while on study prior to surgery;
- Treatment with a prior investigational medication within 30 days of first dose of study agent;
- Any previous local treatment of the prostate (e.g. radiation, HIFU, cryotherapy, Focal Irreversible Electroporation, Photodynamic Therapy, Laser Induced Thermometry);
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- Any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule;
- Known sensitivity to any of the study agent components;
- History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Missouri
Columbia, Missouri, 65212
Henry Ford Health System
Detroit, Michigan, 48202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.
Read the detailed description
NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, this submicron particle paclitaxel will be injected directly into the prostate lesion in men with prostate cancer scheduled for prostatectomy on up to three different occasions. All subjects in the study will receive NanoPac and will be evaluated to see if NanoPac is safe, well-tolerated, and has an impact on prostate cancer.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Adenocarcinoma, Prostatic Neoplasm, Urogenital Neoplasms, Genital Neoplasms, Male
- Being tested
- NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
- Keywords
- paclitaxel
- Medical subject headings
- Prostatic Neoplasms, Urogenital Neoplasms, Genital Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoPac (sterile nanoparticulate paclitaxel) Powder for SuspensionDrug
Also called paclitaxel
NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation.
| Study group | Role | What they receive |
|---|---|---|
| NanoPac | Experimental | Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose. Receives: Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Measured: Day 1 to Day 85
Secondary outcomes (10)
Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)
Prostate tissue samples obtained from a biopsy performed prior to baseline and prostatectomy. Histologic evaluation of these samples will be used to determine the Gleason score, and the results at baseline and Day 92 will be used to evaluate the tumor response to NanoPac. The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly; a higher Gleason score is likely to indicate a worse outcome. The Gleason score is used to help plan treatment and determine prognosis.
Measured: Up to 2 weeks prior to Day 1 and Day 92
Tumor Response Based on Change in Percentage of Sample Considered Adenocarcinoma
Tissues excised from the dominant lesion during prostatectomy (Day 92) will be evaluated for the percentage considered adenocarcinoma and compared to biopsy sample obtained at baseline.
Measured: Up to 2 weeks prior to Day 1 and Day 92
Tumor Invasion Into Surrounding Tissues
The proportion of subjects with local invasion as measured by mpMRI at the final study visit will be compared to screening (baseline)
Measured: Up to 1 month prior to Consent and Day 85
Tumor Response Based on Change in Image Volume on mpMRI
Tumor response to treatment with NanoPac will be determined by evaluating the change in image volume with multiparametric MRI (mpMRI) obtained prior to consent and again at the final study visit.
Measured: Up to 1 month prior to Consent and Day 85
Change in PSA Density
PSA density (PSAD), is a calculation of the serum PSA level divided by the volume of the prostate gland. PSA density has been used as a prognostication tool in helping decide treatment approach. PSA density measured at the final study visit will be compared to screening (baseline)
Measured: Up to 2 weeks prior to Day 1 and Day 85
Change in PI-RADS Score
The Prostate Imaging Reporting and Data System (PI-RADS) assessment uses a five-point scale based on the probability that a combination of mpMRI findings on T2 weighting (T2W), Diffusion Weighted Imaging (DWI), and Dynamic Contrast Enhancement (DCE) correlates with the presence of a clinically significant cancer in the prostate gland. A PI-RADS score of 1 is considered to be most probably benign and a score of 5 is considered to be highly suspicious of prostate malignancy. PI-RADS score will be measured at screening (baseline) and at the final study visit.
Measured: Up to 2 weeks prior to Day 1 and Day 85
Effect on Tumor Presence in Lymph Nodes
Optional PSMA PET scan performed prior to first NanoPac injection and prior to prostatectomy
Measured: Up to 2 weeks prior to Day 1 and Day 92
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Pharmacokinetic samples will be obtained on days of NanoPac injection and other clinic visits.
Measured: Days 1, 8, 15, 29, 36, 43, 50, 57, 64, 71, and 85
Presence or Absence of Paclitaxel in Ejaculate
Ejaculate samples will be collected for analysis of the presence or absence of paclitaxel.
Measured: Days 15, 43, 57, and 85
Presence or Absence of Paclitaxel in Tissues Obtained at Prostatectomy
At the time of prostatectomy, available tissues including the tumor, the ipsilateral lobe of the prostate, the contralateral lobe of the prostate, and pelvic lymph nodes, will be evaluated for the presence or absence of paclitaxel
Measured: Day 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start20 Oct 2020
- Primary completion27 Jan 2021
- Study completion8 Feb 2021
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single group, safety, efficacy, and pharmacokinetic study.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanOlogy, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Biotest, Inc.
- Responsible party
- Sponsor
- Investigators
- Shelagh Verco, PhD, Study director, US Biotest, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221828
- Sponsor's protocol ID
- NANOPAC-2019-01
- Status last verified
- Mar 2022
- First submitted
- 7 Jan 2020
- Last updated
- 29 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04221828
- Acronym / sponsor ID
- NANOPAC-2019-01
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Adenocarcinoma, Prostatic Neoplasm, Urogenital Neoplasms, Genital Neoplasms, Male
- Keywords
- paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- NanOlogy, LLCIndustry (pharma, biotech, devices)
- Collaborators
- US Biotest, Inc.
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Posted 29 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.
Detailed description
NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, this submicron particle paclitaxel will be injected directly into the prostate lesion in men with prostate cancer scheduled for prostatectomy on up to three different occasions. All subjects in the study will receive NanoPac and will be evaluated to see if NanoPac is safe, well-tolerated, and has an impact on prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single group, safety, efficacy, and pharmacokinetic study.
| Arm | Type | Receives |
|---|---|---|
| NanoPac | Experimental | Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for SuspensionDirect injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- At least 18 years of age;
- Histopathologically proven adenocarcinoma of the prostate:
- Prostate tumor must be able to be visualized on mpMRI;
- Already considered to be candidate for radical prostatectomy;
- Considered appropriate for treatment with paclitaxel therapy;
Key exclusion criteria (9 listed)
- Evidence of locally advanced or metastatic disease;
- Prostate size ≥ 50 cc;
- Prior prostatectomy, including surgery for any benign condition (such as TURP);
- Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) while on study prior to surgery;
- Treatment with a prior investigational medication within 30 days of first dose of study agent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoPac (sterile nanoparticulate paclitaxel) Powder for SuspensionAlso: paclitaxelNanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation. | Drug | NanoPac |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: Day 1 to Day 85
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
10 secondary outcomes
Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)
Time frame: Up to 2 weeks prior to Day 1 and Day 92
Tumor Response Based on Change in Percentage of Sample Considered Adenocarcinoma
Time frame: Up to 2 weeks prior to Day 1 and Day 92
Tumor Invasion Into Surrounding Tissues
Time frame: Up to 1 month prior to Consent and Day 85
Tumor Response Based on Change in Image Volume on mpMRI
Time frame: Up to 1 month prior to Consent and Day 85
Change in PSA Density
Time frame: Up to 2 weeks prior to Day 1 and Day 85
Change in PI-RADS Score
Time frame: Up to 2 weeks prior to Day 1 and Day 85
Effect on Tumor Presence in Lymph Nodes
Time frame: Up to 2 weeks prior to Day 1 and Day 92
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Time frame: Days 1, 8, 15, 29, 36, 43, 50, 57, 64, 71, and 85
Presence or Absence of Paclitaxel in Ejaculate
Time frame: Days 15, 43, 57, and 85
Presence or Absence of Paclitaxel in Tissues Obtained at Prostatectomy
Time frame: Day 92
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelagh Verco, PhD study director
US Biotest, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension in people with Prostate Cancer and Prostate Adenocarcinoma, run by NanOlogy, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (time frame: Day 1 to Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.