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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

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Trial Conditions
  • Prostate Cancer
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Male

Eligibility

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 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

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)

- 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
registration

- 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

PRIOR CONCURRENT THERAPY:

- 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
duration

- 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

Gender: Male
Steward Physician(s)
  • Alan Pollack, MD, PhD
  • Leonard G. Gomella, MD
  • Joycelyn L. Speight, MD, PhD
Facilities
  • Saint Anne's Hospital - Recruiting
Trial Interventions
Drug
  • bicalutamide
  • flutamide
Radiation
  • radiation therapy
For more information about this trial, contact

Clinical Trials Office - Hudner Oncology Center at Saint Anne'

Phone: (508) 674-5600


Physician Researcher

Investigator Name:

  • Alan Pollack, MD, PhD
  • Leonard G. Gomella, MD
  • Joycelyn L. Speight, MD, PhD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00567580
Volunteers:  Not Accepting Healthy Volunteers

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