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Phase II Trial of Temporary Androgen Deprivation Therapy in High Risk Prostate Cancer Following Radical Prostatectomy


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase II Trial of Temporary Androgen Deprivation Therapy in High Risk Prostate Cancer Following Radical Prostatectomy


PRIMARY OBJECTIVES:

I. To compare the difference in the biochemical progression-free survival rate (bPFS) at
2-years between immediate ADT for nine months in high risk prostate cancer patients
following radical prostatectomy and a similar high risk patient population followed without
initiation of immediate ADT treatment.

SECONDARY OBJECTIVES:

I. To determine the three year difference in bPFS, prostate cancer specific survival, and
overall survival between immediate ADT for nine months and observation for high risk
prostate cancer patients following radical prostatectomy. II. To evaluate the toxicity
profile and quality of life (QOL) measured by FACT-P and linear analogue self assessment
(LASA) between two treatment arms.

TERTIARY OBJECTIVES:

I. To explore if serum and urine biomarker(s) levels at study entry, 9 months, or 24 months
in the two treatment arms are correlated with biochemical progression-free survival rate.

II. To explore if > 5 circulating tumor cells (CTCs) or circulating endothelial cells (CECs)
following study treatments are associated with biochemical progression-free survival rate.

III. To explore the prognostic and predictive value of tissue based biomarkers in high risk
prostate cancer patients.

OUTLINE:

This is a randomized phase II study.

Patients are stratified according to pathological Gleason score (6-7 vs >=8) and baseline
PSA at diagnosis (<10 ng/mL vs >=10 ng/mL). Patients are randomized to 1 of 2 arms.

Arm A: Patients receive leuprolide acetate intramuscularly on day 1 OR goserelin acetate
subcutaneously on day 1. Treatment repeats every 3 months for a up to 3 courses in the
absence of disease progression or unacceptable toxicity.

Arm B: Patients undergo observation every 3 months for 9 months. After completion of study
treatment, patients are followed every three months for 2 years. PROJECTED ACCRUAL: A total
of 128 patients will be accrued for this study.

Inclusion Criteria


Inclusion:

Prostate cancer patients with high-risk features may be screened for participation either
prior to (pre-registration) or after (registration) radical prostatectomy

Pre-registration: Informed consent explained and signed prior to any study related
procedures

Pre-registration: Patients with any one of the following "high risk" criteria: clinical or
pathological Gleason score 8-10; PSA > 20 ng/mL at initial presentation prior to radical
prostatectomy

Pre-registration: Willingness to provide mandatory tissue for research purposes

Pre-registration: Willingness to provide mandatory blood for research purposes

Registration: ECOG performance status of 0, 1, or 2; or Karnofsky performance of > 60%

Registration: Patients with any one of the following "high risk" criteria: GPSM score >=
10 [GS + 1*(PSA 4-10)+2*(PSA 10.1-20)+3*(PSA>20)+2*(Seminal Vesicular or nodal
involvement) +2*(margin)] (determined post radical prostatectomy)

Registration: Patients with any one of the following "high risk" criteria (continued from
previous criterion): post prostatectomy seminal vesicle invasion (pT3b) or pT4; two or
less microscopic lymph nodal metastasis determined at the time of prostatectomy; or
Gleason 4+3 at the time of prostatectomy with margin positivity

Registration: Please contact study investigator and/or consult protocol document for
specific details on laboratory criteria

Registration:

High risk patients will do one of the following:

1. for patients identified as high-risk on the basis of pathological criteria after
undergoing radical prostatectomy: interval time for study enrollment after radical
prostatectomy will be <= 28 days of the prostatectomy;

2. for patients identified as high-risk prior to undergoing radical prostatectomy:
patients presenting with a high Gleason score (8-10) and/or a PSA >20 ng/ml are
deemed eligible for study participation and study registration as long as the
eligibility criteria is re-confirmed post radical prostatectomy

Registration: These patient groups may choose to register prior to or after prostatectomy

Registration: Study randomization must occur =< 28 days of radical prostatectomy

Registration: All patients consented on the trial, whether consented in the
pre-prostatectomy or postprostatectomy period, will be randomized to study treatments =<
28 days of prostatectomy

Registration: Ability to complete questionnaire(s) by themselves or with assistance

Exclusion

Pre-registration: Transitional cell, small cell, or squamous cell carcinoma of the
prostate

Pre-registration: Patients consented for participation prior to prostatectomy, if detected
to have above listed histo-pathologies after prostatectomy will be deemed ineligible and
not proceed to study randomization

Pre-registration: History of primary prostate cancer treatment

Pre-registration: Evidence of clinical nodal disease (N1) or grossly evident metastasis at
the time of enrollment

Pre-registration: Androgen deprivation therapy within the past 6 months (these agents
include LHRH agonists, anti-androgens, 5 alpha-reductase inhibitors, estrogens,
ketoconazole, or corticosteroids or peripheral anti-androgens)

Pre-registration: History of bilateral orchiectomy

Pre-registration: Unilateral orchiectomy with normal range serum testosterone levels will
be allowed for enrollment

Pre-registration: Evidence of metastasis on radiographic metastatic workup within a
preceding period of 4 months from the time of study entry, including whole body
radionuclide bone scan, CT and/or MR scan of the pelvis and abdomen; otherwise will
perform at the time of the baseline tests and result must be normal to continue on study

Pre-registration: Results of ProstaScint or other radionuclide scans, excluding
radionuclide bone scans, will NOT be used to establish metastatic disease if all other
studies are negative

Pre-registration: Receiving other experimental drugs =< 4 weeks prior to consenting
Pre-registration: Uncontrolled infection

Pre-registration: History of other cancer, excluding squamous cell and basal cell skin
cancers, within the preceding 2 years

Pre-registration: Documented history of HIV positivity or other acquired immunodeficiency
disorder, congenital immunodeficiency disorder, or history of organ transplantation

Pre-registration: Unable to follow up every three months for the first year to Mayo
Clinic, Rochester for receiving LHRH analogues or study monitoring

Registration: Uncontrolled infection Registration: Unable to follow up every three months
for the first year to Mayo Clinic, Rochester for receiving LHRH analogues or study
monitoring

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemical progression-free survival rate

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Robert Karnes, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

MC0852

NCT ID:

NCT00937768

Start Date:

October 2009

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905