Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/21/2018 |
Start Date: | December 2006 |
A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as
goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel
and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount
of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and
leuprolide or goserelin before surgery is more effective than surgery alone in treating
patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to
see how well they work when given before surgery compared with surgery alone in treating
patients with high-risk localized prostate cancer.
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as
goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel
and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount
of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and
leuprolide or goserelin before surgery is more effective than surgery alone in treating
patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to
see how well they work when given before surgery compared with surgery alone in treating
patients with high-risk localized prostate cancer.
This randomized trial tests whether the addition of chemohormonal therapy improves
PSA-progression free survival in patients with high risk, clinically-localized prostate
cancer. The neoadjuvant approach is taken since there appears to be a higher acceptance rate
in the prostate population for this type of therapy and several phase II trials have
demonstrated its safety. Multiple chemotherapeutic therapies have shown efficacy in advanced
prostate cancer and docetaxel has become the community standard. Many high risk patients are
initiated on LHRH agonists at or near the time of diagnosis of their prostate cancer. In
order to allow the inclusion of these patients in the protocol, enhanced enrollment and
maintain compliance with therapy, up to 3 months of androgen deprivation therapy prior to
enrollment will be permitted. This study will therefore be able to test the hypothesis that
targeting both androgen-sensitive and chemotherapy- sensitive prostate cancer cells will
improve outcomes in these high-risk patients.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
nomogram-predicted biochemical progression-free survival at 5 years (0-20.9% vs 21-39.9% vs
40-59.9% vs ≥ 60%) and androgen-deprivation therapy prior to randomization ≤ 4 months (no vs
yes). Patients are randomized to 1 of 2 treatment arms. Please see the Arms sections for more
details.
The primary and secondary objectives are described below.
Primary:
- To determine whether treatment with neoadjuvant docetaxel and androgen deprivation therapy
prior to radical prostatectomy will increase the rate of 3-year biochemical progression-free
survival (bPFS) compared to treatment with immediate radical prostatectomy alone for
high-risk prostate cancer patients.
Secondary:
- To compare the 5-year bPFS rate, bPFS, disease progression, disease-free survival, and
overall survival of patients randomized to the two arms of this trial
- To determine the safety and tolerability of neoadjuvant docetaxel and androgen
deprivation therapy prior to surgery for high-risk patients undergoing radical
prostatectomy
- To compare the impact of neoadjuvant docetaxel and androgen deprivation therapy on time
to clinically apparent local disease recurrence and metastatic disease in high-risk
patients undergoing radical prostatectomy for clinically localized prostate cancer
- To compare the impact of neoadjuvant docetaxel and androgen deprivation therapy relative
to RP on pathologic tumor stage, frequency of lymph node metastases and positive margin
rates for high-risk patients undergoing radical prostatectomy for clinically localized
prostate cancer
- To determine if changes in serum testosterone levels will predict bPFS
- To determine prospectively whether PSA doubling time (PSADT) is a surrogate endpoint for
time to clinical metastases and overall survival
Patients are followed up to 15 years post-randomization.
PSA-progression free survival in patients with high risk, clinically-localized prostate
cancer. The neoadjuvant approach is taken since there appears to be a higher acceptance rate
in the prostate population for this type of therapy and several phase II trials have
demonstrated its safety. Multiple chemotherapeutic therapies have shown efficacy in advanced
prostate cancer and docetaxel has become the community standard. Many high risk patients are
initiated on LHRH agonists at or near the time of diagnosis of their prostate cancer. In
order to allow the inclusion of these patients in the protocol, enhanced enrollment and
maintain compliance with therapy, up to 3 months of androgen deprivation therapy prior to
enrollment will be permitted. This study will therefore be able to test the hypothesis that
targeting both androgen-sensitive and chemotherapy- sensitive prostate cancer cells will
improve outcomes in these high-risk patients.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
nomogram-predicted biochemical progression-free survival at 5 years (0-20.9% vs 21-39.9% vs
40-59.9% vs ≥ 60%) and androgen-deprivation therapy prior to randomization ≤ 4 months (no vs
yes). Patients are randomized to 1 of 2 treatment arms. Please see the Arms sections for more
details.
The primary and secondary objectives are described below.
Primary:
- To determine whether treatment with neoadjuvant docetaxel and androgen deprivation therapy
prior to radical prostatectomy will increase the rate of 3-year biochemical progression-free
survival (bPFS) compared to treatment with immediate radical prostatectomy alone for
high-risk prostate cancer patients.
Secondary:
- To compare the 5-year bPFS rate, bPFS, disease progression, disease-free survival, and
overall survival of patients randomized to the two arms of this trial
- To determine the safety and tolerability of neoadjuvant docetaxel and androgen
deprivation therapy prior to surgery for high-risk patients undergoing radical
prostatectomy
- To compare the impact of neoadjuvant docetaxel and androgen deprivation therapy on time
to clinically apparent local disease recurrence and metastatic disease in high-risk
patients undergoing radical prostatectomy for clinically localized prostate cancer
- To compare the impact of neoadjuvant docetaxel and androgen deprivation therapy relative
to RP on pathologic tumor stage, frequency of lymph node metastases and positive margin
rates for high-risk patients undergoing radical prostatectomy for clinically localized
prostate cancer
- To determine if changes in serum testosterone levels will predict bPFS
- To determine prospectively whether PSA doubling time (PSADT) is a surrogate endpoint for
time to clinical metastases and overall survival
Patients are followed up to 15 years post-randomization.
1. Histologic documentation - Histologic documentation of prostatic adenocarcinoma.
Patients with small cell, neuroendocrine, or transitional cell carcinomas are not
eligible.
All eligible patients must have a known Gleason sum based on biopsy or TURP at the
time of registration.
2. Clinically localized disease - Patients must have clinical stage T1-T3a and no
radiographic evidence of metastatic disease as demonstrated by:
- EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that
demonstrate no nodes > 1.5 cm. If one or more pelvic lymph node(s) measures > 1.5
cm, a negative biopsy is required. If more than one lymph node is > 1.5 cm, the
largest or most accessible node should be biopsied.
AND
- Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if
necessary). Positive PET and Prostascint scans are not considered proof of
metastatic disease.
3. Determination of high-risk status: Patients must have either:
- A Kattan nomogram predicted probability of being free from biochemical
progression at 5 years after surgery of < 60%.
OR
- Prostate biopsy Gleason sum ≥ 8 (NOTE: The Kattan nomogram probability must be
calculated for all patients, including those eligible based on Gleason sum ≥ 8
only.)
4. Prior treatment - No prior treatment for prostate cancer including prior surgery
(excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.
Patients may have received up to 4 months of androgen deprivation therapy (LHRH
agonists, antiandrogens, or both) prior to being enrolled on the study.
5. Appropriate surgical candidates - Patients must be appropriate candidates for radical
prostatectomy with an estimated life expectancy > 10 years as determined by a
urologist. Evidence of underlying cardiac disease should be evaluated prior to
enrollment to ensure that patients are not at high risk of cardiac complications.
6. Clotting history - Patients with a history of deep venous thrombosis, pulmonary
embolism, and/or cerebrovascular accident or currently requiring systemic
anticoagulation are eligible provided they are determined to be candidates for radical
prostatectomy.
7. ECOG performance status: 0-2
8. Age: ≥ 18 years of age
9. Required Initial Laboratory Values:
- ANC ≥ 1500/μL
- Platelet count ≥ 150,000/μL
- Creatinine ≤ 2.0 mg/dL
- Pre-registration serum PSA level ≤ 100 ng/mL
- Bilirubin ≤ 1.5XULN (2.5XULN in patients with Gilbert's disease)
- AST/ALT ≤1.5XULN
We found this trial at
222
sites
2501 N Orange Ave # 235
Orlando, Florida 32804
Orlando, Florida 32804
(407) 303-1700
Florida Hospital Cancer Institute at Florida Hospital Orlando FHCI is the largest cancer center in...
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1201 Camino de Salud Northeast
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(505) 272-4946
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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200 Hawthorne Lane
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4725 North Federal Highway
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85 Retreat Ave # 2
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1900 South Avenue
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1800 West Charleston Boulevard
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One Medical Center Drive
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601 Elmwood Avenue
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4117 East Fowler Avenue
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1 Medical Center Blvd
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
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1.877.590.5995
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4950 Essen Ln
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(225) 767-0847
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2450 Ashby Ave.
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1351 Kimberly Rd
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(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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1101 N 27th St # 201
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2900 12th Ave N Ste 160W
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3110 MacCorkle Ave. S.E.
Charleston, West Virginia 25304
Charleston, West Virginia 25304
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250 Pleasant Street
Concord, New Hampshire 03301
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603-224-2556
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11850 Blackfoot St. NW
Suite 130
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
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18101 Oakwood Blvd
Dearborn, Michigan 48124
Dearborn, Michigan 48124
(313) 593-8620
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2300 N. Edward Street
Decatur, Illinois 62526
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217-876-8121
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Detroit, Michigan 48202
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(888) 777-4167
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Fridley, Minnesota 55432
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Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 685-5225
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1117 29th St S
Great Falls, Montana 59405
Great Falls, Montana 59405
(406) 771-7300
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
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114 Woodland St, Hartford
Hartford, Connecticut 06105
Hartford, Connecticut 06105
(860) 714-4000
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1329 Lusitana St. Ste 307
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
808.524.6115
OnCare Hawaii, Incorporated - Lusitana OnCare Hawaii is a Certified PROVENGE® Treatment Center. PROVENGE (sipuleucel-T)...
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1301 Punchbowl Street
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Cancer Institute at Queen's Medical Center The Queen
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1319 Punahou St
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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