Trial Outcomes & Findings for Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer (NCT NCT01076335)
NCT ID: NCT01076335
Last Updated: 2016-09-19
Results Overview
Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml - 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
1 Year
Results posted on
2016-09-19
Participant Flow
Recruitment Period: Enrollment took place from 21 April 2005 to 31 March 2008. All recruitment done at The University of Texas MD Anderson Cancer Center.
Of the 40 enrolled, one participant (2.5%) declined presurgical therapy after enrollment and was excluded from subsequent analyses.
Participant milestones
| Measure |
Neoadjuvant Hormones + Docetaxel
One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m\^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Neoadjuvant Hormones + Docetaxel
One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m\^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Withdrawal without treatment
|
1
|
Baseline Characteristics
Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Hormones + Docetaxel
n=40 Participants
One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m\^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
|
|---|---|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: One participant of 40 enrolled declined presurgical therapy after enrollment and was excluded from analysis.
Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml - 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted.
Outcome measures
| Measure |
Neoadjuvant Hormones + Docetaxel
n=39 Participants
One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m\^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
|
|---|---|
|
Number of Participants Progression Free at 1 Year
|
13 participants
|
Adverse Events
Neoadjuvant Hormones + Docetaxel
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neoadjuvant Hormones + Docetaxel
n=39 participants at risk
One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m\^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Investigations
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Musculoskeletal and connective tissue disorders
Edema: limb
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
15.4%
6/39 • Number of events 6 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specity)
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Investigations
Hemoglobin decrease
|
12.8%
5/39 • Number of events 5 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary/upper respiratory(Nose)
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Investigations
Leukocytes Low (Total White Blood Count)
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Psychiatric disorders
Mood alteration--Depression
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
General disorders
Nausea
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Nervous system disorders
Neuropathy: sensory
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Eye disorders
Ocular/Visual-Other
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Renal and urinary disorders
Uric acid, serum-high (hyperuricemia)
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
7.7%
3/39 • Number of events 3 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Investigations
Weight loss
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Renal and urinary disorders
Bladder spasms
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Infections and infestations
Superficial wound infection
|
7.7%
3/39 • Number of events 3 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Gastrointestinal disorders
Ileus
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Injury, poisoning and procedural complications
Anastomotic urine leak
|
5.1%
2/39 • Number of events 2 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Vascular disorders
Pelvic lymphocele
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Injury, poisoning and procedural complications
Anastomotic stricture
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
|
Cardiac disorders
Myocardial infarction
|
2.6%
1/39 • Number of events 1 • Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
|
Additional Information
Lance Pagliaro, MD
The University of Texas (UT) MD Anderson Cancer Center
Phone: 1-877-632-6789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place