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Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA Failure With Biopsy Proven Local Recurrence After Initial Definitive Radiotherapy

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA Failure With Biopsy Proven Local Recurrence After Initial Definitive Radiotherapy

In this study, all participants will receive cabazitaxel chemotherapy, which is approved as
a second line chemotherapy for treating metastatic prostate cancer. Standard hormone or
androgen ablation therapy will also be used as part of the chemohormonal therapy prior to
the surgery.

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
- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Surgical Margin Negative Rate (SM Rate)

Outcome Description:

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.

Outcome Time Frame:

On study through end of follow-up - up to 10 years

Safety Issue:


Principal Investigator

Julio Pow-Sang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2012

Completion Date:

April 2022

Related Keywords:

  • Prostate Cancer
  • recurrent
  • high risk
  • Prostatic Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612