Surgical Margin Negative Rate (SM Rate)
| Group | Value (percentage of participants) |
|---|---|
| Experimental: Drug and Hormonal Therapy With Salvage Surgery | 100 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: low accrual
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA
NCT01531205May 2012 to Oct 2013
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The aim of this study is to test whether adding chemotherapy/cabazitaxel and hormonal/androgen deprivation therapy before surgical removal of your prostate would improve the outcome of salvage surgery for locally recurrent prostate cancer after the initial primary radiation therapy.
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
Outcomes the sponsor listed as primary.
Surgical Margin Negative Rate (SM Rate)
Time frame · One Year
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.
Incidence of PSA Progression Free Survival (PFS)
Time frame · Four Months
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.
Incidence of Complete Response (CR)
Time frame · One Year
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.
Incidence of Perioperative and Postoperative Morbidity
Time frame · One Year
Number of events. To access the perioperative and postoperative morbidity with salvage surgery after neoadjuvant hormonal ablation and Cabazitaxel.
Incidence of Detecting Circulating Tumor Cells (CTC)
Time frame · One Year
To determine the feasibility of detecting circulating tumor cells in this patient population. CTC results per patient in milliliters.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Experimental: Drug and Hormonal Therapy With Salvage Surgery | 100 |
| Group | Value (percentage of participants) |
|---|---|
| Experimental: Drug and Hormonal Therapy With Salvage Surgery | 0 |
| Group | Value (percentage of participants) |
|---|---|
| Experimental: Drug and Hormonal Therapy With Salvage Surgery | 0 |
| Group | Value (events) |
|---|---|
| Experimental: Drug and Hormonal Therapy With Salvage Surgery | 0 |
| Group | Value (CTC/mL) |
|---|---|
| Participant One | 2 |
| Participant Two | 1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Experimental: Drug and Hormonal Therapy With Salvage SurgeryAndrogen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up | – | 0 / 2 | 2 / 2 |
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