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A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy



- 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.


- 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 Common Toxicity Criteria for Adverse
Effects (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.


- To assess whether an incremental gain in FFP and survival with more aggressive therapy
outweighs decrements in the primary generic domains of HRQOL (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

OUTLINE: Patients are stratified according to seminal vesicle involvement (yes vs no),
prostatectomy Gleason score (≤ 7 vs 8-9), 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 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 (started within 1-14 days
prior to the LHRH agonist and ending the last day of radiotherapy ± 14 days). Patients
receive LHRH agonist injection beginning concurrently with or 2 weeks after the start
of antiandrogen therapy. LHRH agonist injection consists 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

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 up every 3 months for 1 year, every
6 months for 4 years, and then annually thereafter.

Inclusion Criteria


- 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 with or without positive prostatectomy margins

- 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 9 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


- 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)

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit
of normal

- No prior invasive malignancy (except nonmelanoma skin cancer) or superficial bladder
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

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for
Disease Control (CDC) definition

- HIV testing is not required for entry

- No prior allergic reaction to the study drug(s) involved in this protocol


- See Disease Characteristics

- More than 5 years since prior chemotherapy for any other disease site

- No androgen-deprivation therapy started prior to prostatectomy for > 6 months

- The use of finasteride or dutasteride (± tamsulosin) for longer periods prior to
prostatectomy is acceptable

- No androgen-deprivation therapy started after prostatectomy and prior to registration

- The use of finasteride or dutasteride (± tamsulosin) after prostatectomy is not
acceptable, it must be stopped within 3 months after prostatectomy

- No neoadjuvant chemotherapy before or after prostatectomy

- No prior cryosurgery or brachytherapy of the prostate (prostatectomy should be the
primary treatment and not a salvage procedure)

- No prior pelvic radiotherapy

Type of Study:


Study Design:

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

Outcome Measure:

Freedom from progression (FFP)

Outcome Time Frame:

From date of randomization to the first occurrence of biochemical failure by the Phoenix definition (PSA >= 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant) or death from any cause.

Safety Issue:


Principal Investigator

Alan Pollack, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:

RTOG 0534



Start Date:

February 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms



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Cancer Centers of the Carolinas - Greer Medical Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas - Seneca Seneca, South Carolina  29672
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
Cancer Centers of the Carolinas - Eastside Greenville, South Carolina  29601
West Tennessee Cancer Center at Jackson-Madison County General Hospital Jackson, Tennessee  38301
Sentara Cancer Institute at Sentara Norfolk General Hospital Norfolk, Virginia  23507
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau, Wisconsin  54401
Solano Radiation Oncology Center Vacaville, California  95687
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Baptist Medical Center South Jascksonville, Florida  32258
Florida Cancer Center - Palatka Palatka, Florida  32177
Flagler Cancer Center Saint Augustine, Florida  32086
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland, New Jersey  08360
Lipson Cancer and Blood Center at Rochester General Hospital Rochester, New York  14621
Tyler Cancer Center Tyler, Texas  75702
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
Boston University Cancer Research Center Boston, Massachusetts  02118
Mercy General Hospital Sacramento, California  95819
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
Memorial Medical Center Modesto, California  95355
El Camino Hospital Cancer Center Mountain View, California  94040
Larry G Strieff MD Medical Corporation Oakland, California  94609
Tom K Lee, Incorporated Oakland, California  94609
Bay Area Breast Surgeons, Incorporated Oakland, California  94609
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
Hawaii Medical Center - East Honolulu, Hawaii  96817
Pacific Cancer Institute - Maui Wailuku, Hawaii  96793
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
Center for Cancer Care at Exeter Hospital Exeter, New Hampshire  03833
Valley Hospital - Ridgewood Ridgewood, New Jersey  07450
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
AnMed Cancer Center Anderson, South Carolina  29621
Franciscan Skemp Healthcare - La Crosse Campus La Crosse, Wisconsin  54601
Cancer Care Center, Incorporated Salem, Ohio  44460
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Center for Cancer Care at Goshen General Hospital Goshen, Indiana  46526
UPMC Cancer Center at UPMC Presbyterian Pittsburgh, Pennsylvania  15213
Cancer Institute of Cape Girardeau, LLC Cape Girardeau, Missouri  63703
Providence Cancer Center at PMCC Medford, Oregon  97504
Veterans Affairs Medical Center - Milwaukee Milwaukee, Wisconsin  53295
Central Maryland Oncology Center Columbia, Maryland  21044
Valley Medical Oncology Consultants - Castro Valley Castro Valley, California  94546
Valley Medical Oncology Fremont, California  94538
Cancer Care Associates Fresno, California  93720
Integrated Community Oncology Network - Orange Park Orange Park, Florida  32073
Mount Sinai Hospital Medical Center Chicago, Illinois  60608
Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River, Massachusetts  02721
Immanuel St. Joseph's Mankato, Minnesota  56002
Columbia Saint Mary's Hospital - Ozaukee Mequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care Center Milwaukee, Wisconsin  53211
Cancer Centers of the Carolinas - Greer Radiation Oncology Greer, South Carolina  29650
Minnesota Oncology - Maplewood Maplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
UPMC Cancer Center at Beaver Medical Center Beaver, Pennsylvania  15009
UPMC Cancer Center at Jefferson Regional Medical Center Clairton, Pennsylvania  15025
UPMC Cancer Center - Arnold Palmer Pavilion Greensburg, Pennsylvania  15601
UPMC Cancer Center at the John P. Murtha Pavilion Johnstown, Pennsylvania  15901
UPMC - Moon Moon Township, Pennsylvania  15108
UPMC Cancer Center - Natrona Heights Natrona Heights, Pennsylvania  15065
Jameson Memorial Hospital - North Campus New Castle, Pennsylvania  16105
UPMC - Shadyside Pittsburgh, Pennsylvania  15213-2582
UPMC Cancer Center at UPMC St. Margaret Pittsburgh, Pennsylvania  15215
UPMC Cancer Center at UPMC Passavant Pittsburgh, Pennsylvania  15237
Washington Hospital Cancer Center Washington, Pennsylvania  15301
Emory Crawford Long Hospital Atlanta, Georgia  30308
Holy Cross Hospital Silver Spring, Maryland  20910
New York Oncology Hematology, PC at Albany Regional Cancer Care Albany, New York  12208
Central Wisconsin Cancer Program at Agnesian HealthCare Fond du Lac, Wisconsin  54935
Auburn Radiation Oncology Auburn, California  95603
Radiation Oncology Centers - Cameron Park Cameron Park, California  95682
Radiation Oncology Center - Roseville Roseville, California  95661
Hudson Valley Oncology Associates Poughkeepsie, New York  12601
Inova Alexandria Hospital Alexandria, Virginia  22304
Mercy Cancer Center at Mercy San Juan Medical Center Carmichael, California  95608
St. Agnes Hospital Cancer Center Baltimore, Maryland  21229
Barnes-Jewish West County Hospital Saint Louis, Missouri  63141
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters Saint Peters, Missouri  63376
Sands Cancer Center Canandiaqua, New York  14424
University Radiation Oncology at Parkridge Hospital Rochester, New York  14626
Coleman Radiation Oncology Center at Carter General Hospital Morehead City, North Carolina  28557
CarolinaEast Cancer Care New Bern, North Carolina  28560
South Atlantic Radiation Oncology, LLC Supply, North Carolina  28462
Coastal Carolina Radiation Oncology Center Wilmington, North Carolina  28401
Norris Cotton Cancer Center - North Saint Johnsbury, Vermont  05819
Langlade Memorial Hospital Antigo, Wisconsin  54409
Integrated Community Oncology Network at Southside Cancer Center Jacksonville, Florida  32207
Southwest General Health Center Middleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical Center Orange Villager, Ohio  44122
UHHS Westlake Medical Center Westlaker, Ohio  44145
Longview Cancer Center Longview, Texas  75601
Piedmont Fayette Hospital Fayetteville, Georgia  30214
Lakeside Hospital Omaha, Nebraska  68130
University of New Mexico Cancer Center - South Las Cruces, New Mexico  88011
Cleveland Clinic Foundation - Strongsville Strongsville, Ohio  44136
Riverview UW Cancer Center at Riverview Hospital Wisconsin Rapids, Wisconsin  54494
Roger Maris Cancer Center at MeritCare Hospital Fargo, North Dakota  58122
Capital Health Regional Cancer Center Trenton, New Jersey  08618
Dyson Center for Cancer Care at Vassar Brothers Medical Center Poughkeepsie, New York  12601-3990
AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus Pomona, New Jersey  08240
Saint Helena Hospital Saint Helena, California  94574
Northeast Radiation Oncology Center Dunmore, Pennsylvania  18512
New Mexico Cancer Center Albuquerque, New Mexico  87109
Southern Ohio Medical Center Cancer Center Portsmouth, Ohio  45662
Arizona Center for Cancer Care - Peoria Peoria, Arizona  85381
Feather River Hospital Cancer Center Paradise, California  95969
Radiation Oncology Associates Southwest Fort Wayne, Indiana  46804
Henry Ford Macomb Hospital Clinton Township, Michigan  48038
McLaren Cancer Institute Flint, Michigan  48532
Willamette Valley Cancer Center - Eugene Eugene, Oregon  97401
Intercommunity Cancer Center Monroeville, Pennsylvania  15146
Texas Oncology, PA at Harris Center HEB Bedford, Texas  76022
Texas Oncology, PA at Texas Cancer Center - Denton South Denton, Texas  76210
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital Fort Worth, Texas  76104
Texas Oncology, PA at Lake Vista Cancer Center Lewisville, Texas  75067
Cancer Care Centers of South Texas - Northeast San Antonio, Texas  78217
Texas Oncology, PA at Texas Cancer Center - Sherman Sherman, Texas  75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land Sugar Land, Texas  77479
Alle-Kiski Medical Center Natrona Heights, Pennsylvania  15065
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Sleepy Hollow, New York  10591
Nebraska Medical Center Omaha, Nebraska  68198
Upper Delaware Valley Cancer Center Milford, Pennsylvania  18337
Arizona Oncology - Tucson Tucson, Arizona  85704
Rocky Mountain Cancer Centers - Aurora Aurora, Colorado  80012
Norton Suburban Hospital Louisville, Kentucky  40207
UPMC Cancer Center at UPMC McKeesport McKeesport, Pennsylvania  15132
UPMC Cancer Center - Upper St. Clair Pittsburgh, Pennsylvania  15243
Door County Cancer Center at Door County Memorial Hospital Sturgeon Bay, Wisconsin  54235-1495
Adams Cancer Center Gettysburg, Pennsylvania  17325
Tate Cancer Center at Baltimore Washington Medical Center Glen Burnie, Maryland  21061
Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center Lincoln, Nebraska  68510
D.N. Greenwald Center Mukwonago, Wisconsin  53149
Coastal Cancer Center at Sentara Virginia Beach General Hospital Virginia Beach, Virginia  23454
Veterans Affairs Medical Center - Tampa Tampa, Florida  33612
Northside Hospital-Forsyth Cumming, Georgia  30041
Memorial Sloan-Kettering Cancer Center - Basking Ridge Basking Ridge, New Jersey  07920
Stich Radiation Center at NewYork-Presbyterian Hospital/Weill Cornell Medical Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center - Rockville Centre Rockville Centre, New York  11570
Tony Teramana Cancer Center Steubenville, Ohio  43952
Hilton Head Radiation Oncology Center Hilton Head Island, South Carolina  29926
Memorial Hermann Hospital - Memorial City Houston, Texas  77024
Texas Oncology, PA - Wichita Falls Wichita Falls, Texas  76310
Beloit Memorial Hospital Beloit, Wisconsin  53511