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CSP #553 - Adjuvant Therapy in Prostate Carcinoma Treatment (CAP)


Phase 3
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

CSP #553 - Adjuvant Therapy in Prostate Carcinoma Treatment (CAP)


VA Cooperative Study #553 is designed to prospectively evaluate the efficacy of early
adjuvant chemotherapy using docetaxel and prednisone added to the standard of care for
patients who are potentially cured by radical prostatectomy but who are at high risk for
relapse. The standard of care is surveillance, with the addition of androgen deprivation at
the time of biochemical relapse. This study will assess the effect of adding early
chemotherapy to the standard of care on progression free survival in veterans at high risk
for progression after prostatectomy.

The ability of radical prostatectomy to cure prostate cancer and to therefore prevent the
morbidity and mortality associated with progression to metastatic disease depends on
effectively treating both local and potential systemic disease. In the United States
alone, over 80,000 men per year are treated with prostatectomy to cure their disease.
Because 20% of these men will be found to have locally advanced or high-grade disease, they
will be at risk for relapse and morbidity from their prostate cancer. Although androgen
deprivation, radiation therapy, and chemotherapy have been considered potentially effective
adjuvant modalities for localized prostate cancer, there are no randomized studies that
support the utility of any of these treatments as a standard of care. Ultimately, it is
androgen independent prostate cancer, which causes morbidity for these patients. Docetaxel
based chemotherapy has been shown to prolong survival and induce responses in up to 80% of
patients with androgen independent disease, generating enthusiasm for the use of
chemotherapy early in the treatment of prostate cancer. This study is designed to test the
value of adjuvant chemotherapy in improving progression free survival, which is critical in
preventing morbidity and mortality from relapse in patients with clinically localized, but
high risk, prostate cancer.

After patients are stratified for PSA, Gleason score, tumor stage, the presence of positive
margins, and the planned use of adjuvant radiation therapy, this study will prospectively
randomize 636 patients from 30 VA sites, after prostatectomy, to the standard of care or to
docetaxel and prednisone administered every 3 weeks for 18 weeks. Patients would then be
observed with PSA for a minimum of one and a maximum of five years. The study is designed
with 90% power to detect a reduction in the 5-year progression rate from 60% to 45% (15%
absolute difference, 25% relative difference).

Prostate cancer is the leading cause of malignancy for veterans, and the second leading
cause of death. Patients with high risk, localized disease account for 70% of all cancer
deaths in patients treated for cure with radical prostatectomy. Effective adjuvant therapy
is critical to reducing suffering and death from prostate cancer. The VA Cooperative Studies
Program is uniquely placed to address this question. The VA has a longstanding history of
important studies in prostate cancer, which have significantly changed the way urologic
oncologists treat patients with this disease. The incidence of prostate cancer in our
older, male population is substantial, the number of veterans treated with prostatectomy
continues to rise, and the incidence of high risk prostate cancer in veterans is greater
than that typically found in the community. For all of these reasons, carrying out this
study within the VA through the VA Cooperative Studies Program is the optimal way to
determine whether adjuvant chemotherapy will benefit men with high risk prostate cancer.


Inclusion Criteria:



1. A histologic diagnosis of cT1-T2 primary adenocarcinoma of the prostate prior to
prostatectomy, with lymph node dissection at time of radical prostatectomy

2. One or more of the following poor prognostic features:

- tumor extension to seminal vesicle (pT3b) or bladder neck (T4)

- established extracapsular extension (pT3a) and Gleason Score >= 7

- organ confined (pT2) with positive surgical margin and Gleason 8-10

- preoperative PSA > 20

3. SWOG performance status 0-1

4. PSA nadir of <= 0.1 ng/ml up to 30 days prior to randomization. Patients must be
randomized within 120 days after prostatectomy.

5. Laboratory values (no more than 30 days before randomization) must be as follows:

- Absolute granulocyte count: >= 1,500/mm3

- Platelets: >= 100,000/mm3

- Hemoglobin: >= 10 g/dL

- Serum Creatinine: <= 1.5 x ULN

- AST: <= 1.5 x ULN

- ALT: <= 1.5 x ULN

- Serum Calcium: <= ULN

- Total Bilirubin: <=ULN

- Plasma Phosphorus Level: <= 6 mg/dl

6. Patients with preoperative PSA > 20 ng/mL must have a negative bone scan within 120
days of randomization

7. A valid, signed, and witnessed informed consent by the patient

Exclusion Criteria:

1. Small cell histology

2. N1 disease or M1 disease

3. Clinical T3 disease prior to prostatectomy

4. Any other investigational therapy

5. An active serious infection or other serious underlying medical condition that would
otherwise impair their ability to receive protocol treatment

6. A history of cancer related hypercalcemia

7. Uncontrolled heart failure

8. Prior malignancy other than curatively treated squamous cell or basal cell carcinoma
of the skin. If another malignancy has been treated and there is no evidence of
relapse > 5 years from the time of treatment, patients are eligible

9. Androgen deprivation, chemotherapy, or radiation therapy to treat prostate carcinoma

10. Current peripheral neuropathy of any etiology that is greater than Grade I

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Daniel Lin

Investigator Role:

Study Chair

Investigator Affiliation:

VA Puget Sound Health Care System, Seattle

Authority:

United States: Federal Government

Study ID:

553

NCT ID:

NCT00132301

Start Date:

June 2006

Completion Date:

April 2013

Related Keywords:

  • Prostate Cancer
  • multi-site clinical trial
  • prostate
  • radical prostatectomy
  • randomized
  • Carcinoma
  • Prostatic Neoplasms

Name

Location

VA Medical Center, DurhamDurham, North Carolina  27705
VA Medical Center, Long BeachLong Beach, California  90822
VA Medical Center, MiamiMiami, Florida  33125
VA Medical Center, BirminghamBirmingham, Alabama  35233
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little RockNo. Little Rock, Arkansas  72114-1706
VA Medical Center, San FranciscoSan Francisco, California  94121
James A. Haley Veterans Hospital, TampaTampa, Florida  33612
Jesse Brown VAMC (WestSide Division)Chicago, Illinois  60612
VA Medical Center, LexingtonLexington, Kentucky  40502
Overton Brooks VA Medical Center, ShreveportShreveport, Louisiana  71101
VA Ann Arbor Healthcare SystemAnn Arbor, Michigan  48113
VA Western New York Healthcare System at BuffaloBuffalo, New York  14215
VA Medical Center, PortlandPortland, Oregon  97201
VA Pittsburgh Health Care SystemPittsburgh, Pennsylvania  15240
VA Medical Center, MemphisMemphis, Tennessee  38104
VA North Texas Health Care System, DallasDallas, Texas  75216
VA Puget Sound Health Care System, SeattleSeattle, Washington  98108
Wlliam S. Middleton Memorial Veterans Hospital, MadisonMadison, Wisconsin  53705
Southern Arizona VA Health Care System, TucsonTucson, Arizona  85723
VA Medical Center, Kansas City MOKansas City, Missouri  64128
Michael E. DeBakey VA Medical Center (152)Houston, Texas  77030
VA Medical Center, MinneapolisMinneapolis, Minnesota  55417
VA Greater Los Angeles Healthcare System, West LAWest Los Angeles, California  90073
VA San Diego Healthcare System, San DiegoSan Diego, California  92161
VA Connecticut Health Care System (West Haven)West Haven, Connecticut  06516
North Florida/South Georgia Veterans Health SystemGainesville, Florida  32608
VA Medical Center, AugustaAugusta, Georgia  30904
John D. Dingell VA Medical Center, DetroitDetroit, Michigan  48201
G.V. (Sonny) Montgomery VA Medical Center, JacksonJackson, Mississippi  39216
New Mexico VA Health Care System, AlbuquerqueAlbuquerque, New Mexico  87108-5153
Ralph H Johnson VA Medical Center, CharlestonCharleston, South Carolina  29401-5799
VA South Texas Health Care System, San AntonioSan Antonio, Texas  78229
VA Salt Lake City Health Care System, Salt Lake CitySalt Lake City, Utah  84148