Trial Outcomes & Findings for Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA (NCT NCT01531205)
NCT ID: NCT01531205
Last Updated: 2014-11-05
Results Overview
Post surgery percentage of participants with negative surgical margin. To determine the surgical margin negative rate in patients who have undergone chemohormonal therapy followed by surgery for biopsy proven androgen-dependent high risk locally recurrent prostate cancer following primary radiation therapy. Margin: The edge or border of the tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.
TERMINATED
PHASE2
2 participants
One Year
2014-11-05
Participant Flow
Participants were recruited at Moffitt Cancer Center from May 15, 2012 to September 27, 2013.
Participant milestones
| Measure |
Experimental: Drug and Hormonal Therapy With Salvage Surgery
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Experimental: Drug and Hormonal Therapy With Salvage Surgery
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
|---|---|
|
Overall Study
Did not proceed to surgery
|
1
|
Baseline Characteristics
Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA
Baseline characteristics by cohort
| Measure |
Experimental: Drug and Hormonal Therapy With Salvage Surgery
n=2 Participants
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One YearPopulation: Participants who proceeded to surgery
Post surgery percentage of participants with negative surgical margin. To determine the surgical margin negative rate in patients who have undergone chemohormonal therapy followed by surgery for biopsy proven androgen-dependent high risk locally recurrent prostate cancer following primary radiation therapy. Margin: The edge or border of the tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.
Outcome measures
| Measure |
Experimental: Drug and Hormonal Therapy With Salvage Surgery
n=1 Participants
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
Participant Two
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
|---|---|---|
|
Surgical Margin Negative Rate (SM Rate)
|
100 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Four MonthsPopulation: Participants who proceeded to surgery
Percentage of participants with stable (has not increased) or undetectable PSA post surgery. To assess Prostate-specific antigen(PSA)-progression free survival and prostate cancer specific survival for patients treated by chemohormonal therapy followed by salvage surgery for biopsy proven androgen-dependent high-risk locally recurrent prostate cancer following radiation therapy.
Outcome measures
| Measure |
Experimental: Drug and Hormonal Therapy With Salvage Surgery
n=1 Participants
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
Participant Two
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
|---|---|---|
|
Incidence of PSA Progression Free Survival (PFS)
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: One YearPopulation: Participants who proceeded to surgery
Percentage of participants with CR post surgery. To evaluate the pathological complete response rate to androgen ablation plus Cabazitaxel in patients with locally recurrent prostate cancer following radiation therapy. Pathological Complete Response (pCR): Participants with no residual cancer in the local resection specimen and pelvic lymph nodes will be considered pCR.
Outcome measures
| Measure |
Experimental: Drug and Hormonal Therapy With Salvage Surgery
n=1 Participants
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
Participant Two
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
|---|---|---|
|
Incidence of Complete Response (CR)
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: One YearPopulation: Participants who proceeded to surgery
Number of events. To access the perioperative and postoperative morbidity with salvage surgery after neoadjuvant hormonal ablation and Cabazitaxel.
Outcome measures
| Measure |
Experimental: Drug and Hormonal Therapy With Salvage Surgery
n=1 Participants
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
Participant Two
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
|---|---|---|
|
Incidence of Perioperative and Postoperative Morbidity
|
0 events
|
—
|
SECONDARY outcome
Timeframe: One YearPopulation: All participants
To determine the feasibility of detecting circulating tumor cells in this patient population. CTC results per patient in milliliters.
Outcome measures
| Measure |
Experimental: Drug and Hormonal Therapy With Salvage Surgery
n=1 Participants
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
Participant Two
n=1 Participants
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
|---|---|---|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
Baseline CK-CTC/mL
|
3 CTC/mL
|
0 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
Baseline CTC/mL
|
2 CTC/mL
|
1 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
1 Month CTC/mL
|
1 CTC/mL
|
6 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
3 Month CTC/mL
|
27 CTC/mL
|
NA CTC/mL
Participant withdrew
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
Baseline CTC Clusters/mL
|
1 CTC/mL
|
0 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
1 Month CTC Clusters/mL
|
0 CTC/mL
|
2 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
3 Month CTC Clusters/mL
|
28 CTC/mL
|
NA CTC/mL
Participant withdrew
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
Baseline Apop/mL
|
1 CTC/mL
|
1 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
1 Month Apop/mL
|
1 CTC/mL
|
4 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
3 Month Apop/mL
|
1 CTC/mL
|
NA CTC/mL
Participant withdrew
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
Baseline Small Cells/mL
|
0 CTC/mL
|
0 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
1 Month Small Cells/mL
|
0 CTC/mL
|
0 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
3 Month Small Cells/mL
|
0 CTC/mL
|
NA CTC/mL
Participant withdrew
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
1 Month CK-CTC/mL
|
0 CTC/mL
|
1 CTC/mL
|
|
Incidence of Detecting Circulating Tumor Cells (CTC)
3 Month CK-CTC/mL
|
18 CTC/mL
|
NA CTC/mL
Participant withdrew
|
Adverse Events
Experimental: Drug and Hormonal Therapy With Salvage Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: Drug and Hormonal Therapy With Salvage Surgery
n=2 participants at risk
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
|
|---|---|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 3 • One year
All participants
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • One year
All participants
|
|
Vascular disorders
Hot flashes
|
100.0%
2/2 • Number of events 3 • One year
All participants
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • One year
All participants
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 2 • One year
All participants
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
50.0%
1/2 • Number of events 1 • One year
All participants
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • One year
All participants
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • One year
All participants
|
|
Renal and urinary disorders
Urinary incontinence
|
50.0%
1/2 • Number of events 1 • One year
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • One year
All participants
|
Additional Information
Julio Pow-Sang, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place