CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation

NCT03657108 | Terminated Results DMC FDA Device

• 2 other identifiers: GCO 16-1314PD 16-03067
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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).

Conditions

Prostate Cancer

Keywords

brachytherapy; prostatectomy; radiation therapy; surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (5)

• Number of Surgical Complications

  intraoperative, postoperative - acute (< 90 days) and late (18 months)

• Number of Participants With Biochemical Recurrence (BCR)

  6-month follow-up after EBRT

• Number of Participants With Erectile Dysfunction

  6 months after EBRT

• Number of Participants With PSA Persistence

  40 months

• Number of Participants With Urinary Incontinence

  at least 6 months after EBRT, up to 40 months

Other Outcomes (3)

• Number of Participants With Acute Radiation Toxicity

  3 months

• Number of Participants With Late Radiation Toxicity

  after 90 days, up to 4 years 10 months

• Number of Radiation Adverse Event(s)

  4 years 10 months

Study Arms (4)

group 1 of 60 Gy dose

EXPERIMENTAL

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; Radiation: Adjuvant external beam radiation therapy

group 2 of 60 Gy dose

EXPERIMENTAL

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; Radiation: Adjuvant external beam radiation therapy

group 1 of 75 Gy dose

EXPERIMENTAL

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; Radiation: Adjuvant external beam radiation therapy

group 2 of 75 Gy dose

EXPERIMENTAL

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; Radiation: Adjuvant external beam radiation therapy

Interventions

Civasheet 60 Gy RADIATION

implantable proposed doses of Civasheet are 60 Gy

group 1 of 60 Gy dose; group 2 of 60 Gy dose

Civasheet 75 Gy RADIATION

implantable proposed doses of Civasheet are 75 Gy

group 1 of 75 Gy dose; group 2 of 75 Gy dose

Adjuvant external beam radiation therapy RADIATION

45 Gy in 25 fractions

Also known as: EBRT

group 1 of 60 Gy dose; group 1 of 75 Gy dose; group 2 of 60 Gy dose; group 2 of 75 Gy dose

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer is a disease that only affects males. Therefore, this protocol will only recruit male patients with a prostate cancer diagnosis.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Mount Sinai West

New York, New York, 10019, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Ketan Badani
• Organization: Icahn School of Medicine at Mount Sinai

ketan.badani@mountsinai.org

(212) 241-3919

Study Officials

• Ketan K. Badani, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 3+3 dose escalation study to determine MTD

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: September 4, 2018
• Study Start: March 27, 2018
• Primary Completion: December 20, 2020
• Study Completion: February 1, 2023
• Last Updated: March 20, 2024
• Results First Posted: March 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Duration of study
• Access Criteria: Employed Mount Sinai Researchers

Locations

US (2)