Clinical Trials /

CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation

NCT03657108

Description:

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).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: GCO 16-1314
  • SECONDARY ID: PD 16-03067
  • NCT ID: NCT03657108

Conditions

  • Prostate Cancer

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
group 1 of 60 Gy doseExperimentalThe first 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy
    group 2 of 60 Gy doseExperimentalThe second 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy
      group 1 of 75 Gy doseExperimentalThe third 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy
        group 2 of 75 Gy doseExperimentalThe fourth 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy

          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).
                
          Maximum Eligible Age:N/A
          Minimum Eligible Age:18 Years
          Eligible Gender:Male
          Healthy Volunteers:No

          Primary Outcome Measures

          Measure:Maximum Tolerable Dose (MTD)
          Time Frame:90 days
          Safety Issue:
          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.

          Secondary Outcome Measures

          Measure:Surgical Complication Rate
          Time Frame:90 days
          Safety Issue:
          Description:Rate for surgical complications, acute (< 90 days) and late (18 months days)
          Measure:Prostate Specific Antigen (PSA)
          Time Frame:5 years
          Safety Issue:
          Description:Serum PSA levels

          Details

          Phase:N/A
          Primary Purpose:Interventional
          Overall Status:Recruiting
          Lead Sponsor:Icahn School of Medicine at Mount Sinai

          Trial Keywords

          • brachytherapy
          • prostatectomy
          • radiation therapy
          • surgery

          Last Updated

          April 18, 2019