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CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation

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ClinicalTrials.gov Identifier: NCT03657108
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ketan Badani, Icahn School of Medicine at Mount Sinai

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Civasheet 60 Gy Radiation: Civasheet 75 Gy Radiation: Adjuvant external beam radiation therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 3+3 dose escalation study to determine MTD
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: group 1 of 60 Gy dose
The first 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy
Radiation: Civasheet 60 Gy
implantable proposed doses of Civasheet are 60 Gy

Radiation: Adjuvant external beam radiation therapy
45 Gy in 25 fractions
Other Name: EBRT

Experimental: group 2 of 60 Gy dose
The second 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy
Radiation: Civasheet 60 Gy
implantable proposed doses of Civasheet are 60 Gy

Radiation: Adjuvant external beam radiation therapy
45 Gy in 25 fractions
Other Name: EBRT

Experimental: group 1 of 75 Gy dose
The third 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy
Radiation: Civasheet 75 Gy
implantable proposed doses of Civasheet are 75 Gy

Radiation: Adjuvant external beam radiation therapy
45 Gy in 25 fractions
Other Name: EBRT

Experimental: group 2 of 75 Gy dose
The fourth 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy
Radiation: Civasheet 75 Gy
implantable proposed doses of Civasheet are 75 Gy

Radiation: Adjuvant external beam radiation therapy
45 Gy in 25 fractions
Other Name: EBRT




Primary Outcome Measures :
  1. Maximum Tolerable Dose (MTD) [ Time Frame: 90 days ]
    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 :
  1. Surgical Complication Rate [ Time Frame: 90 days ]
    Rate for surgical complications, acute (< 90 days) and late (18 months days)

  2. Prostate Specific Antigen (PSA) [ Time Frame: 5 years ]
    Serum PSA levels


Other Outcome Measures:
  1. Acute radiation toxicity [ Time Frame: 3 months ]
    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

  2. Late radiation toxicity [ Time Frame: 5 years ]
    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

  3. Radiation adverse event(s) [ Time Frame: 5 years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657108


Contacts
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Contact: Kennedy E Okhawere, MD, MPH 212-659-9373 kennedy.okhawere@mountsinai.org

Locations
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United States, New York
Mount Sinai West Recruiting
New York, New York, United States, 10019
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Ketan K. Badani, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Ketan Badani, Principal Investigator, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03657108     History of Changes
Other Study ID Numbers: GCO 16-1314
PD 16-03067 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Duration of study
Access Criteria: Employed Mount Sinai Researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Ketan Badani, Icahn School of Medicine at Mount Sinai:
brachytherapy
prostatectomy
radiation therapy
surgery

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases