Trial Outcomes & Findings for Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer (NCT NCT00321698)
NCT ID: NCT00321698
Last Updated: 2024-08-29
Results Overview
Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel. The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling). MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
5 weeks
Results posted on
2024-08-29
Participant Flow
Subject accrual from Urology clinics started in April 2006; annual follow-up of 22 VA, 3 Oregon Health \& Science University (OHSU) (25 total) subjects who completed ended in 2011; 10 year follow-up of these patients will be completed in 2021.
Our 1 screen failure was excluded as a result of having a different type of cancer, other than non-melanoma skin cancer, within the past 5 years.
Participant milestones
| Measure |
Phase I, Radiation Only
Group 1=radiation only;
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 1
Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation;
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.
|
Phase I, Dose 2
Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation;
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.
|
Phase I, Dose 3
Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation;
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.
|
Phase II, MTD Dose
MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
Phase I, Rad Only & Dose 1-3
STARTED
|
3
|
3
|
3
|
3
|
0
|
|
Phase I, Rad Only & Dose 1-3
COMPLETED
|
3
|
3
|
3
|
3
|
0
|
|
Phase I, Rad Only & Dose 1-3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase II, MTD Dose
STARTED
|
0
|
0
|
0
|
0
|
13
|
|
Phase II, MTD Dose
COMPLETED
|
0
|
0
|
0
|
0
|
13
|
|
Phase II, MTD Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Phase I, Radiation Only
n=3 Participants
Drug: N/A
4 groups of men in phase I study.
Group 1=radiation only
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 1
n=3 Participants
Drug: docetaxel
4 groups of men in phase I study.
Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
n=3 Participants
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
n=3 Participants
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
n=13 Participants
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Age, Continuous
|
66.67 years
STANDARD_DEVIATION 8.14 • n=5 Participants
|
62.67 years
STANDARD_DEVIATION 7.64 • n=7 Participants
|
66.33 years
STANDARD_DEVIATION 4.93 • n=5 Participants
|
58.00 years
STANDARD_DEVIATION 6.56 • n=4 Participants
|
60.54 years
STANDARD_DEVIATION 4.58 • n=21 Participants
|
61.92 years
STANDARD_DEVIATION 5.89 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
13 participants
n=21 Participants
|
25 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: Outcome analysis includes the subjects from all 4 phase I groups, inclusive of subjects who only received radiation, as all subjects across all phases received the same radiation dosage. Phase I, group 1 subjects were included in case MTD was zero.
Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel. The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling). MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped.
Outcome measures
| Measure |
Phase I Dose 1-4
n=12 Participants
4 groups of men in phase I study.
Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
|
Phase II MTD Dose
Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
30 mg/m^2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 4-6 weeks after study treatmentPathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.
Outcome measures
| Measure |
Phase I Dose 1-4
n=13 Participants
4 groups of men in phase I study.
Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
|
Phase II MTD Dose
Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
Pathologic Response Rate at the Phase II Dose
Pathologic Stage pT2c
|
7 participants
|
—
|
—
|
—
|
—
|
|
Pathologic Response Rate at the Phase II Dose
Pathologic Stage pT3a
|
3 participants
|
—
|
—
|
—
|
—
|
|
Pathologic Response Rate at the Phase II Dose
Pathologic Stage pT3b
|
3 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment) and 1 month after surgery (post-treatment)Population: Pre- and post-treatment PSA values were available in 22 of 25 patients.
All participants were combined for this assessment as pre-specified in the protocol. The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported. PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years
Outcome measures
| Measure |
Phase I Dose 1-4
n=22 Participants
4 groups of men in phase I study.
Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
|
Phase II MTD Dose
Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA
|
-49.1 percentage change
Interval -60.3 to -36.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Regular intervals both study-related and clinical standard of care-related; assessed at end of study treatment. Average timeframe to follow safety was 1 year and includes all grade 3-4 adverse eventsPopulation: Phase I participants numbered 12 (receiving different chemotherapy doses) and Phase II participants numbered 13 (receiving the maximally tolerated chemotherapy dose). This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, per protocol.
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Outcome measures
| Measure |
Phase I Dose 1-4
n=12 Participants
4 groups of men in phase I study.
Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
|
Phase II MTD Dose
n=13 Participants
Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
Long-term Safety
|
9 grade 3-4 adverse events
|
8 grade 3-4 adverse events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Each participant was examined 3, 6, 9, 12 months, and annually for an average of 10 years after surgery.Population: Clinical response to treatment was measured by regular Prostatic Specific Antigen (PSA) blood draws. The following men per chemotherapy dosage experienced a detectable or rising PSA value after surgery with a 2nd confirmatory level of 0.2ng/mL or higher (defined as biochemical recurrence of prostate cancer).
Biochemical Recurrence is defined as a detectable or rising PSA value after surgery that is 0.2 ng/mL or greater with a second confirmatory level of 0.2 ng/mL or greater.
Outcome measures
| Measure |
Phase I Dose 1-4
n=3 Participants
4 groups of men in phase I study.
Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
|
Phase II MTD Dose
n=3 Participants
Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
n=3 Participants
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
n=3 Participants
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
n=13 Participants
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
Clinical Response to Treatment as Measured by Urologic Examination
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: For Phase I Dose 1-4, all participants were combined for this assessment as pre-specified in the protocol.
Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body.
Outcome measures
| Measure |
Phase I Dose 1-4
n=12 Participants
4 groups of men in phase I study.
Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
|
Phase II MTD Dose
n=13 Participants
Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 Months Post-ProstatectomyPopulation: Scores not available for some participants
Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score. AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe. EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL.
Outcome measures
| Measure |
Phase I Dose 1-4
n=25 Participants
4 groups of men in phase I study.
Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
|
Phase II MTD Dose
Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures
AUA Symptom Score
|
0.67 units on a scale
Interval -2.96 to 4.29
|
—
|
—
|
—
|
—
|
|
Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures
EPIC Urinary Incontinence Score
|
-36.52 units on a scale
Interval -51.38 to -21.67
|
—
|
—
|
—
|
—
|
|
Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures
EPIC Bowel
|
1.45 units on a scale
Interval -6.42 to 9.33
|
—
|
—
|
—
|
—
|
|
Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures
EPIC Hormonal
|
0.00 units on a scale
Interval -6.42 to 6.42
|
—
|
—
|
—
|
—
|
|
Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures
EPIC Sexual
|
-36.26 units on a scale
Interval -48.84 to -23.68
|
—
|
—
|
—
|
—
|
|
Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures
EPIC Urinary Obstructive/Irritative Score
|
3.41 units on a scale
Interval -5.55 to 12.37
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, 12 months and annually, up to 5 yearsThe estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.
Outcome measures
| Measure |
Phase I Dose 1-4
n=25 Participants
4 groups of men in phase I study.
Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
|
Phase II MTD Dose
Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
Clinical Progression-free Rate as Determined by <0.1ng PSA Results
|
62.8 percentage of participants
Interval 41.9 to 83.6
|
—
|
—
|
—
|
—
|
Adverse Events
Phase I, Radiation Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I, Dose 1
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I, Dose 2
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I, Dose 3
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II, MTD Dose
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I, Radiation Only
n=3 participants at risk
Drug: N/A
4 groups of men in phase I study.
Group 1=radiation only
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 1
n=3 participants at risk
Drug: docetaxel
4 groups of men in phase I study.
Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 2
n=3 participants at risk
Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase I, Dose 3
n=3 participants at risk
Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
Phase II, MTD Dose
n=13 participants at risk
Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
|
|---|---|---|---|---|---|
|
General disorders
Difficulty with ADLs
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
33.3%
1/3 • Number of events 2 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/13 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
66.7%
2/3 • Number of events 2 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
33.3%
1/3 • Number of events 2 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
7.7%
1/13 • Number of events 1 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
15.4%
2/13 • Number of events 4 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
|
Blood and lymphatic system disorders
Lymphapenia
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
33.3%
1/3 • Number of events 1 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
33.3%
1/3 • Number of events 2 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
38.5%
5/13 • Number of events 5 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
|
Blood and lymphatic system disorders
Hemoglobin (L)
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
33.3%
1/3 • Number of events 1 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
33.3%
1/3 • Number of events 1 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/13 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/13 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/13 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
|
Surgical and medical procedures
Pain
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
33.3%
1/3 • Number of events 1 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/3 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
0.00%
0/13 • Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place