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Trial Outcomes & Findings for CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation (NCT NCT03657108)

NCT ID: NCT03657108

Last Updated: 2024-03-20

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

90 days

Results posted on

2024-03-20

Participant Flow

Participant milestones

Participant milestones
Measure
60 Gy
CivaSheet 60 Gy with fixed dose of adjuvant EBRT (45Gy)
75Gy
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
First Dose 60 Gy (90 Days Post EBRT)
STARTED
1
0
First Dose 60 Gy (90 Days Post EBRT)
COMPLETED
1
0
First Dose 60 Gy (90 Days Post EBRT)
NOT COMPLETED
0
0
Next 2 Dose 60 Gy
STARTED
2
0
Next 2 Dose 60 Gy
COMPLETED
2
0
Next 2 Dose 60 Gy
NOT COMPLETED
0
0
First Dose 75 Gy (90 Days Post EBRT)
STARTED
0
1
First Dose 75 Gy (90 Days Post EBRT)
COMPLETED
0
0
First Dose 75 Gy (90 Days Post EBRT)
NOT COMPLETED
0
1
Next 2 Dose 75 Gy
STARTED
0
2
Next 2 Dose 75 Gy
COMPLETED
0
2
Next 2 Dose 75 Gy
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
60 Gy
n=3 Participants
CivaSheet 60 Gy with fixed dose of adjuvant EBRT (45Gy)
75Gy
n=3 Participants
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Total
n=6 Participants
Total of all reporting groups
Age, Continuous
56 years
n=99 Participants
56 years
n=107 Participants
56 years
n=206 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Male
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Race/Ethnicity, Customized
Non-Hispanic White
0 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Race/Ethnicity, Customized
Hispanic
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
American Society of Anesthesiologists score (ASA)
I
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
American Society of Anesthesiologists score (ASA)
II
1 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
American Society of Anesthesiologists score (ASA)
III
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Magnetic Resonance Image (MRI) Tumor size
3 cm
n=99 Participants
1.5 cm
n=107 Participants
2.7 cm
n=206 Participants
MRI extracapsular extension
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
MRI seminal vesicle infiltration
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
MRI nodal disease
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
MRI metastasis
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Baseline Prostate-Specific Antigen (PSA)
26.3 ng/mL
n=99 Participants
38.6 ng/mL
n=107 Participants
32.5 ng/mL
n=206 Participants
Biopsy grade group
1
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Biopsy grade group
2
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Biopsy grade group
3
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Biopsy grade group
4
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Biopsy grade group
5
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
All Participants
n=6 Participants
All participants who received at least 1 dose of CivaSheet, either at 60 Gy or 75 Gy with fixed dose of adjuvant external beam radiation therapy (EBRT) (45Gy)
75Gy
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Maximum Tolerable Dose (MTD)
75 Gy
—

SECONDARY outcome

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

Number of surgical major complications (major complications defined as Clavien≥3.): intraoperative, post operative - acute (\< 90 days) and late (18 months). Grade III - Requiring surgical, endoscopic or radiological intervention Grade IV - Life-threatening complication (including central nervous system (CNS) complications) requiring intensive care (IC/ICU)-management Grade V - Death of a patient

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of CivaSheet, either at 60 Gy or 75 Gy with fixed dose of adjuvant external beam radiation therapy (EBRT) (45Gy)
75Gy
n=3 Participants
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Number of Surgical Complications
Intraoperative complication
0 Participants
0 Participants
Number of Surgical Complications
Postoperative complication
0 Participants
0 Participants
Number of Surgical Complications
intraoperative, postoperative - acute (< 90 days) and late (18 months)
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 6-month follow-up after EBRT

Number of participants with Biochemical recurrence (BCR) at 6-month follow-up after EBRT. BCR was defined as a post-prostatectomy serum prostate-specific antigen (PSA) level greater than 0.2 nanograms per milliliter (ng/mL).

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of CivaSheet, either at 60 Gy or 75 Gy with fixed dose of adjuvant external beam radiation therapy (EBRT) (45Gy)
75Gy
n=3 Participants
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Number of Participants With Biochemical Recurrence (BCR)
1 Participants
0 Participants

SECONDARY outcome

Timeframe: 6 months after EBRT

Number of participants with Erectile Dysfunction at least 6 months after EBRT

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of CivaSheet, either at 60 Gy or 75 Gy with fixed dose of adjuvant external beam radiation therapy (EBRT) (45Gy)
75Gy
n=3 Participants
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Number of Participants With Erectile Dysfunction
3 Participants
2 Participants

SECONDARY outcome

Timeframe: 40 months

Number of participants with PSA persistence which is defined as PSA persistently greater than 0.2 ng/mL after surgery.

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of CivaSheet, either at 60 Gy or 75 Gy with fixed dose of adjuvant external beam radiation therapy (EBRT) (45Gy)
75Gy
n=3 Participants
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Number of Participants With PSA Persistence
1 Participants
0 Participants

SECONDARY outcome

Timeframe: at least 6 months after EBRT, up to 40 months

Number of Participants with Urinary Incontinence at least 6 months after EBRT

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of CivaSheet, either at 60 Gy or 75 Gy with fixed dose of adjuvant external beam radiation therapy (EBRT) (45Gy)
75Gy
n=3 Participants
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Number of Participants With Urinary Incontinence
0 Participants
0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Number of participants with Acute (occurring within 90 days) radiation toxicity using the Radiation Therapy Oncology Group (RTOG) Acute Toxicity Scale and Late Radiation Morbidity scales; including Grade 4-5 hematuria, fistula formation, proctitis or death.

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of CivaSheet, either at 60 Gy or 75 Gy with fixed dose of adjuvant external beam radiation therapy (EBRT) (45Gy)
75Gy
n=3 Participants
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Number of Participants With Acute Radiation Toxicity
0 Participants
1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: after 90 days, up to 4 years 10 months

Number of participants with Late (occurring after 90 days) radiation toxicity using the Radiation Therapy Oncology Group (RTOG) Acute Toxicity Scale and Late Radiation Morbidity scales; including Grade 4-5 hematuria, fistula formation, proctitis or death.

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of CivaSheet, either at 60 Gy or 75 Gy with fixed dose of adjuvant external beam radiation therapy (EBRT) (45Gy)
75Gy
n=3 Participants
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Number of Participants With Late Radiation Toxicity
0 Participants
0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years 10 months

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

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of CivaSheet, either at 60 Gy or 75 Gy with fixed dose of adjuvant external beam radiation therapy (EBRT) (45Gy)
75Gy
n=3 Participants
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Number of Radiation Adverse Event(s)
Grade 1 - Mild Adverse Event
0 Participants
1 Participants
Number of Radiation Adverse Event(s)
Grade 2 - Moderate Adverse Event
0 Participants
0 Participants
Number of Radiation Adverse Event(s)
Grade 3 - Serious Adverse Event
0 Participants
0 Participants
Number of Radiation Adverse Event(s)
Grade 4 - Life-threatening Adverse Event
0 Participants
0 Participants
Number of Radiation Adverse Event(s)
Grade 5 - Fatal Adverse Event
0 Participants
0 Participants

Adverse Events

60 Gy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

75Gy

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
60 Gy
n=3 participants at risk
CivaSheet 60 Gy with fixed dose of adjuvant EBRT (45Gy)
75Gy
n=3 participants at risk
CivaSheet 75 Gy with fixed dose of adjuvant EBRT (45Gy)
Renal and urinary disorders
Radiation cystitis
0.00%
0/3 • 4 years, 10 months for participants who received EBRT 1 year for participants who did not receive EBRT
33.3%
1/3 • 4 years, 10 months for participants who received EBRT 1 year for participants who did not receive EBRT

Additional Information

Ketan Badani

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-3919

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place