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CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Civasheet 60 Gy
Civasheet 75 Gy
Adjuvant external beam radiation therapy
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring brachytherapy, prostatectomy, radiation therapy, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Any subject with National Comprehensive Cancer Network (NCCN) very high or high risk adenocarcinoma of the prostate defined as ≥T3a, Gleason score ≥ 8, or PSA > 20 who is eligible for RP (open or robotic) with adjuvant EBRT as an initial treatment option.
  • Any subject with NCCN Intermediate Risk adenocarcinoma of the prostate defined as T2b-T2c, Gleason score 7, or PSA 10-20 who is eligible for RP (open or robotic) with adjuvant EBRT as an initial treatment option and at least one of the following adverse features present in pre-operative imaging: seminal vesicle infiltration (SVI), extracapsular extension (ECE), N1 disease.
  • Subject must have had a pre-operative MRI or must obtain a pre-operative MRI to be eligible for participation in this study.
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Any subject who has undergone prior radiation to the pelvis.
  • Subjects presenting with distant metastases.
  • On any investigational drug(s), androgen deprivation therapy or therapeutic device(s) within 30 days preceding screening.
  • Currently taking immunosuppressants, or with poorly controlled diabetes (HbA1c >8).

Sites / Locations

  • Mount Sinai WestRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

group 1 of 60 Gy dose

group 2 of 60 Gy dose

group 1 of 75 Gy dose

group 2 of 75 Gy dose

Arm Description

The first 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy

The second 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy

The third 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy

The fourth 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy

Outcomes

Primary Outcome Measures

Maximum Tolerable Dose (MTD)
MTD is defined as the highest dose of the Civasheet® not yielding unacceptable toxicity. Specifically if > 33 % of subjects experience dose limiting toxicity (DLT) at any dose level, the dose level below that level will be considered the MTD.

Secondary Outcome Measures

Surgical Complication Rate
Rate for surgical complications, acute (< 90 days) and late (18 months days)
Prostate Specific Antigen (PSA)
Serum PSA levels

Full Information

First Posted
July 11, 2018
Last Updated
February 23, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03657108
Brief Title
CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation
Official Title
A Phase I Single-Arm Open Label Dose-Escalation Study of CivaSheet With Radical Prostatectomy With or Without Adjuvant External Beam Radiation Therapy in Patients With High Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase I single-arm open label dose escalation study to evaluate the maximum tolerated dose (MTD) and safety of Civasheet® with radical prostatectomy (RP) and adjuvant external beam radiation therapy (EBRT) in a 3+3 dose escalation design among participants with high risk prostate cancer (PCa).
Detailed Description
Using preoperative MRI imaging to identify areas suspicious of local advancement in addition to identifying areas with a higher likelihood of a positive margin during RP due to the presence of high risk features, Civasheet® and its inherently flexible structure allow the sheet to be directly implanted on areas suspicious for local advancement and positive surgical margins for direct application of radiation to these areas. The custom, single planar layer, integrative gold shielding of Civasheet® also allows radiation to be provided unidirectionally to allow healthy tissue (i.e., bladder, rectum) to be shielded from radiation; possibly affording a lower rate of gastrointestinal (GI) and genitourinary (GU) toxicity and adverse events. During EBRT, radiation especially for high risk PCa is provided at high rates to the entire prostatic bed with the seminal vesicles, pelvic lymph nodes and a surrounding margin often targeted to eliminate positive margins and cancer from locally advanced areas in which the cancer may have spread (i.e., seminal vesicles, bladder neck). These high rates of radiation often damage surrounding tissue and result in rectal and bladder complications in addition to urethral strictures among other adverse complications. Since Civasheet® will provide radiation to the prostatic bed, a lower dose of EBRT will be used to treat the prostatic bed and potentially lower adverse bladder and rectal effects compared to RP + RT at 60 Gy. 103 Pd seeds of Civasheet® also illuminate on imaging. Therefore placing Civasheet® based on pre-operative identification of areas suspicious for local advancement and areas of likely positive surgical margins during RP will allow for targeted EBRT to the locally advanced areas. Since EBRT can be targeted using Civasheet®, a lower and more direct dose of radiation during EBRT may be used to treat local advancement and positive surgical margins which will potentially reduce toxicity and complications associated with higher doses of radiation. The above properties are likely to facilitate improved cancer control with more direct and local application of radiation to areas of local advancement surrounding the prostate. These features are also likely to facilitate a reduced complication and toxicity profile since Civasheet® allows EBRT to be applied more accurately and at a lower dose and also the unidirectional radiation applied directly by Civasheet® protects surrounding healthy tissue from receiving radiation.No other studies have attempted to use Civasheet® to improve PCa control and reduce toxicity and complications associated with radiation for participants with high-risk prostate cancer. The investigators anticipate that implanting Civasheet® on areas suspicious for local advancement and positive margins based on pre-operative MRI findings and identification of high risk features in addition to relying on the illumination provided by Civasheet® for targeted adjuvant EBRT will provide a safer complication profile and eventually provide evidence for superior cancer control, lower toxicity and less adverse events than EBRT+ RP alone in a future randomized controlled trial. The investigators therefore propose a phase I single-arm open label dose escalation study to evaluate the MTD and safety of Civasheet® with RP and adjuvant EBRT in a 3+3 dose escalation design among participants with high risk PCa.With this study, the investigators to better understand the MTD, safety and toxicity profile of Civasheet® in the setting of RP + adjuvant EBRT in the treatment of high-risk PCa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
brachytherapy, prostatectomy, radiation therapy, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
3+3 dose escalation study to determine MTD
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1 of 60 Gy dose
Arm Type
Experimental
Arm Description
The first 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy
Arm Title
group 2 of 60 Gy dose
Arm Type
Experimental
Arm Description
The second 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy
Arm Title
group 1 of 75 Gy dose
Arm Type
Experimental
Arm Description
The third 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy
Arm Title
group 2 of 75 Gy dose
Arm Type
Experimental
Arm Description
The fourth 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Civasheet 60 Gy
Intervention Description
implantable proposed doses of Civasheet are 60 Gy
Intervention Type
Radiation
Intervention Name(s)
Civasheet 75 Gy
Intervention Description
implantable proposed doses of Civasheet are 75 Gy
Intervention Type
Radiation
Intervention Name(s)
Adjuvant external beam radiation therapy
Other Intervention Name(s)
EBRT
Intervention Description
45 Gy in 25 fractions
Primary Outcome Measure Information:
Title
Maximum Tolerable Dose (MTD)
Description
MTD is defined as the highest dose of the Civasheet® not yielding unacceptable toxicity. Specifically if > 33 % of subjects experience dose limiting toxicity (DLT) at any dose level, the dose level below that level will be considered the MTD.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Surgical Complication Rate
Description
Rate for surgical complications, acute (< 90 days) and late (18 months days)
Time Frame
90 days
Title
Prostate Specific Antigen (PSA)
Description
Serum PSA levels
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Acute radiation toxicity
Description
Acute radiation toxicity scale of Radiation Therapy Oncology Group (RTOG); 4 Grades where Grade 1 is the better outcome and Grade 4 is the worse outcome
Time Frame
3 months
Title
Late radiation toxicity
Description
Late radiation toxicity scale of Radiation Therapy Oncology Group (RTOG); 4 Grades where Grade 1 is the better outcome and Grade 4 is the worse outcome
Time Frame
5 years
Title
Radiation adverse event(s)
Description
National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0); 5 Grades where Grade 1 is the better outcome and Grade 5 is the worse outcome
Time Frame
5 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer is a disease that only affects males. Therefore, this protocol will only recruit male patients with a prostate cancer diagnosis.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any subject with National Comprehensive Cancer Network (NCCN) very high or high risk adenocarcinoma of the prostate defined as ≥T3a, Gleason score ≥ 8, or PSA > 20 who is eligible for RP (open or robotic) with adjuvant EBRT as an initial treatment option. Any subject with NCCN Intermediate Risk adenocarcinoma of the prostate defined as T2b-T2c, Gleason score 7, or PSA 10-20 who is eligible for RP (open or robotic) with adjuvant EBRT as an initial treatment option and at least one of the following adverse features present in pre-operative imaging: seminal vesicle infiltration (SVI), extracapsular extension (ECE), N1 disease. Subject must have had a pre-operative MRI or must obtain a pre-operative MRI to be eligible for participation in this study. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Any subject who has undergone prior radiation to the pelvis. Subjects presenting with distant metastases. On any investigational drug(s), androgen deprivation therapy or therapeutic device(s) within 30 days preceding screening. Currently taking immunosuppressants, or with poorly controlled diabetes (HbA1c >8).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kennedy E Okhawere, MD, MPH
Phone
212-659-9373
Email
kennedy.okhawere@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketan K. Badani, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data (IPD) sharing plan will be based on sharing patient information on REDcap. REDcap is an electronic database that will be used to share the data with other researcher.
IPD Sharing Time Frame
Duration of study
IPD Sharing Access Criteria
Employed Mount Sinai Researchers

Learn more about this trial

CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation

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