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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA

Overview

Status
Terminated
Phase
Phase 2
Enrollment
2 participants (actual)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
May 2012
Primary completion
Sept 2013
Completion
Oct 2013
First posted
10 Feb 2012 (estimated)
Last update posted
5 Nov 2014 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 2

    Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA

    NCT01531205

    May 2012 to Oct 2013

    Terminated

Registry summary

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.

Interventions

  • Androgen AblationDrug
  • CabazitaxelDrug
  • Salvage TherapyDrug
  • Neoadjuvant Treatment - Hormonal TherapyDrug
  • Neoadjuvant Treatment - CabazitaxelDrug

Arms1

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Surgical Margin Negative Rate (SM Rate)

    Time frame · One Year

    Registry description

    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.

Secondary outcomes(4)
  1. Incidence of PSA Progression Free Survival (PFS)

    Time frame · Four Months

    Registry description

    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.

  2. Incidence of Complete Response (CR)

    Time frame · One Year

    Registry description

    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.

  3. Incidence of Perioperative and Postoperative Morbidity

    Time frame · One Year

    Registry description

    Number of events. To access the perioperative and postoperative morbidity with salvage surgery after neoadjuvant hormonal ablation and Cabazitaxel.

  4. Incidence of Detecting Circulating Tumor Cells (CTC)

    Time frame · One Year

    Registry description

    To determine the feasibility of detecting circulating tumor cells in this patient population. CTC results per patient in milliliters.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· One Year

Surgical Margin Negative Rate (SM Rate)

GroupValue (percentage of participants)
Experimental: Drug and Hormonal Therapy With Salvage Surgery100
Secondary and other outcome results(4)
Secondary outcomeNumber· Four Months

Incidence of PSA Progression Free Survival (PFS)

GroupValue (percentage of participants)
Experimental: Drug and Hormonal Therapy With Salvage Surgery0
Secondary outcomeNumber· One Year

Incidence of Complete Response (CR)

GroupValue (percentage of participants)
Experimental: Drug and Hormonal Therapy With Salvage Surgery0
Secondary outcomeNumber· One Year

Incidence of Perioperative and Postoperative Morbidity

GroupValue (events)
Experimental: Drug and Hormonal Therapy With Salvage Surgery0
Secondary outcomeNumber· One Year

Incidence of Detecting Circulating Tumor Cells (CTC)

GroupValue (CTC/mL)
Participant One2
Participant Two1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 22 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy must be more than 10 years * Peripheral neuropathy: must be \</= grade 1 * A minimum PSA of 1 ng/ml if not on androgen deprivation therapy * Patients must have one of the following criteria to be eligible: * PSA recurrence with a doubling time of less than 9 months (calculated by at least 3 PSA values that were obtained at least 4 weeks apart) * Prostatic biopsy Gleason Grade of \>/= 8 at the time of initial biopsy prior to radiation therapy and as determined by either an outside pathology report or on review of slides by our institutional pathologist(s) * Clinical stage of \>/= T3 (defined as evidence of extracapsular or seminal vesicle extension on digital rectal examination or transrectal ultrasonography) either at the time of initial diagnosis or following radiotherapy * Prior radiation therapy of any type including external beam radiotherapy, brachytherapy, high dose radiotherapy, or proton therapy * Positive prostate biopsy documenting local recurrence following radiation therapy * Prior androgen deprivation therapy up to a total duration of 36 months is allowable. * Patients who are on LHRH analog therapy should continue such therapy provided that the patient does not have castration resistant prostate cancer (rising PSA in the presence of castrate levels of serum testosterone, ie \< 50 ng/dl). Androgen deprivation therapy other than LHRH analog should be discontinued 4 weeks prior to study enrollment. * All prostatic carcinoma variants except small cell carcinoma of the prostate will be allowed. * Patients must have no evidence of metastatic diseases on the bone scan and an abdominal/pelvic CT or MRI performed within 30 days of study enrollment. * All patients must be regarded as acceptable anesthetic risk for salvage surgery (salvage radical prostatectomy, salvage cystoprostatectomy, salvage total pelvic exenteration) and confirm their intention to undergo salvage surgery at the end of the neoadjuvant chemohormonal therapy. * Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of \> 1,500/mm\^3 and platelet count of \> 100,000/mm\^3; adequate hepatic function defined with a total bilirubin of \< 1.5 mg/dl and aspartic transaminase/alanine transaminase (AST/ALT) \< 1.5 X the upper limits of normal (ULN); adequate renal function defined as serum creatinine clearance \> 60 ml/min (measured or calculated). * Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. * Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution. * All patients must be evaluated in the Department of Genitourinary Oncology prior to signing informed consent. Exclusion Criteria: * Patients with small cell histology * Patients with clinical, radiological, or pathological evidence of bone, lymph node or visceral metastasis (liver or lung metastasis) * Castration resistant prostate cancer defined as rising PSA profile in setting of castrate levels of testosterone (serum testosterone \< 50 ng/dl) * Prior chemotherapy * Patients with severe or uncontrolled intercurrent infection * Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or history of myocardial infarction within the last 6 months * Contraindications to corticosteroids * Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus, oxygen dependent lung disease, chronic liver disease or HIV infection * Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years * Overt psychosis, mental disability or otherwise incompetent to give informed consent * Patients with a history of severe hypersensitivity reaction to Cabazitaxel® or other drugs formulated with polysorbate 80

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