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View Clinical Trial (Medical Research Study)
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Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising PSA After Surgery for Prostate Cancer - NCT00567580-98405C (Clinical Trial 193538)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy193538.aspx
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| City: |
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Tacoma |
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State:
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WA |
| Zip Code: |
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98405 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can
cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide,
bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of
androgens made by the body. It is not yet known which regimen of radiation therapy with or
without androgen deprivation therapy is more effective for prostate cancer.
PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how
well it works compared with short-term androgen deprivation therapy given together with
pelvic lymph node radiation therapy with or without prostate radiation therapy in treating
patients with a rising PSA after surgery for prostate cancer.
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| Study summary: |
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OBJECTIVES:
Primary
- To determine whether the addition of short-term androgen deprivation (STAD) to prostate
bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e., maintenance of a
prostate-specific antigen [PSA] less than the nadir+2 ng/mL, absence of clinical
failure, and absence of death from any cause) for 5 years, over that of PBRT alone in
men treated with salvage radiotherapy after radical prostatectomy.
- To determine whether STAD, pelvic lymph node radiotherapy (PLNRT), and PBRT improves
FFP over that of STAD+PBRT and PBRT alone in men treated with salvage radiotherapy
after radical prostatectomy.
Secondary
- To compare the rates of a PSA ≥ 0.4 ng/mL and rising at 5 years after randomization
(secondary biochemical failure endpoint), the development of hormone refractory disease
(3 rises in PSA during treatment with salvage androgen deprivation therapy), distant
metastasis, cause-specific mortality, and overall mortality.
- To compare acute and late morbidity based on CTCAE, v. 3.0.
- To measure the expression of cell kinetic, apoptotic pathway, and angiogenesis-related
genes in archival diagnostic tissue to better define the risk of FFP, distant failure,
cause-specific mortality, and overall mortality after salvage radiotherapy for prostate
cancer, independently of conventional clinical parameters now used.
- To quantify blood product-based proteomic and genomic (single nucleotide polymorphisms)
patterns and urine-based genomic patterns before and at different times after treatment
to better define the risk of FFP, distant failure, cause-specific mortality, and
overall mortality after salvage radiotherapy for prostate cancer, independently of
conventional clinical parameters now used.
- To assess the degree, duration, and significant differences of disease-specific
health-related quality of life (HRQOL) decrements among treatment arms.
- To assess whether mood is improved and depression is decreased with the more aggressive
therapy if it improves FFP.
- To collect paraffin-embedded tissue blocks, serum, plasma, urine, and buffy coat cells
for future translational research analyses.
Tertiary
- To assess whether an incremental gain in FFP and survival with more aggressive therapy
outweighs decrements in the primary generic domains of health related quality of life
(i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression).
- To evaluate the cost-utility of the treatment arm demonstrating the most significant
benefit (in terms of the primary outcome) in comparison with other widely accepted
cancer and non-cancer therapies.
- To assess associations between serum levels of beta-amyloid and measures of cognition
and mood and depression.
- An exploratory aim is to assess the relationship(s) between the American Urological
Association Symptom Index (AUA SI) and urinary morbidity using the CTCAE v. 3.0 grading
system.
OUTLINE: Patients are stratified according to seminal vesicle involvement (yes vs no),
prostatectomy Gleason score (≤ 7 vs 8), pre-radiotherapy PSA (≥ 0.1 and ≤ 1.0 ng/mL vs > 1.0
and < 2.0 ng/mL), and pathology stage (pT2 and margin negative vs all others). Patients are
randomized to 1 of 3 treatment arms.
- Arm I (prostate bed radiotherapy [PBRT] alone): Patients undergo PBRT once daily, 5
days a week, Monday through Friday, for approximately 7-8 weeks (36 to 39 fractions).
- Arm II (PBRT and short-term androgen deprivation [STAD]): Beginning 2 months before the
start of PBRT, patients undergo short term androgen deprivation (STAD), using a
combination of antiandrogen and luteinizing hormone-releasing hormone (LHRH) agonist
therapy, for a total of 4-6 months. Patients receive antiandrogen therapy comprising
either oral flutamide 3 times daily or oral bicalutamide once daily for at least 4
months. Patients receive LHRH agonist injection beginning concurrently with or 2 weeks
after the start of antiandrogen therapy. LHRH agonist injection consist of analogs
approved by the FDA (or by Health Canada for Canadian institutions) (e.g., leuprolide,
goserelin, buserelin, or triptorelin) and may be given in any possible combination (may
be given as a single 4-month injection and one to two 1-month injection[s], two 3-month
injections, or a 6-month injection), such that the total LHRH agonist treatment time is
4-6 months. Approximately 2 months after beginning of STAD, patients undergo PBRT as in
arm I.
- Arm III (Pelvic lymph node radiotherapy [PLNRT], PBRT, and STAD): Beginning 2 months
before the start of radiotherapy, patients receive STAD therapy as in arm II.
Approximately 2 months after beginning of STAD, patients undergo PBRT and PLNRT once
daily, 5 days a week, Monday through Friday, for approximately 5 weeks (25 fractions)
followed by PBRT only once daily, 5 days a week for approximately 2-3 weeks (11-14
fractions).
Patients complete the American Urological Association Symptom Index (AUA SI) questionnaire
prior to protocol treatment, at week 6 of radiotherapy, and then periodically after
completion of study therapy.
After completion of study therapy, patients are followed every 3 months for 1 year, every 6
months for 4 years, and then annually thereafter. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Adenocarcinoma of the prostate treated primarily with radical prostatectomy
- Pathologically proven to be lymph node-negative by pelvic lymphadenectomy (N0)
or lymph node status pathologically unknown (Nx [undissected pelvic lymph nodes
because lymph node dissection is not required])
- Any type of radical prostatectomy allowed, including retropubic, perineal,
laparoscopic or robotically assisted
- Meets 1 of the following pathologic classifications:
- T3 N0/Nx disease
- T2 N0/Nx disease with or without positive prostatectomy margins
- N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥
1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the
enlarged lymph node is negative
- Prostatectomy Gleason score of 8 or less
- A post-radical prostatectomy entry PSA of ≥ 0.1 and ≤ 1.0 ng/mL at least 6 weeks
after prostatectomy and within 30 days of registration
- Serum total testosterone ≥ 40% of the lower limit of normal (patients who have had a
unilateral orchiectomy are eligible as long as this requirement is met)
- No distant metastases based on history/physical examination, CT scan or MRI of the
abdomen and pelvis, and bone scan
- No palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown
by biopsy under ultrasound guidance not to contain cancer
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Platelets ≥ 100,000/mm^3
- Hemoglobin ≥ 10.0 g/dL (the use of transfusion or other intervention to achieve this
is allowed)
- AST or ALT < 2 x upper limit of normal
- No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for
a minimum of 5 years (e.g., carcinoma in situ of the oral cavity is permissible)
- No severe, active co-morbidity, including any of the following:
- History of inflammatory bowel disease
- History of hepatitis B or C
- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of
registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
- HIV testing is not required for entry
- No prior allergic reaction to the study drug(s) involved in this protocol
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No androgen deprivation therapy started prior to prostatectomy for > 6 months
duration
- No androgen deprivation therapy started after prostatectomy and prior to registration
- No prior pelvic radiotherapy |
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| Study is available at: |
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MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, WA 98405
United States
Primary Contact:
Clinical Trials Office - MultiCare Regional Cancer Center
Phone: 253-403-3229 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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