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 Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Radiation Therapy Oncology Group
Sponsor:
Collaborators:
Cancer and Leukemia Group B
NRG Oncology Foundation, Inc.
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00567580
First received: December 4, 2007
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: flutamide
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Freedom from progression (FFP) [ 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary biochemical failure [ Time Frame: From date of randomization to a detectable PSA rising for at least two values with the second value at 0.4 ng/mL or greater. ] [ Designated as safety issue: No ]
  • Hormone-refractory disease [ Time Frame: From the date of randomization to the third of three rises of PSA after the institution of salvage hormone therapy. ] [ Designated as safety issue: No ]
  • Local failure [ Time Frame: From the date of randomization to the development of a new palpable abnormality in the prostate bed after enrollment in the protocol. ] [ Designated as safety issue: No ]
  • Distant metastasis [ Time Frame: From randomization to documented (by imaging) distant disease. ] [ Designated as safety issue: No ]
  • Cause-specific mortality [ Time Frame: From date of randomization to the date of death due to prostate cancer. ] [ Designated as safety issue: No ]
  • Overall mortality [ Time Frame: From the date of randomization to the date of death due to any cause. ] [ Designated as safety issue: No ]
  • Incidence of acute adverse events ≤ 90 days of the completion of radiotherapy (RT) [ Time Frame: From the date radiation treatment completion to the first occurrence of worst severity of an adverse event within 90 days. ] [ Designated as safety issue: Yes ]
  • Time to late grade 2+ and 3+ adverse events assessed > 90 days from the completion of RT [ Time Frame: From date of randomization to the first occurrence of grade 2+ or 3+ adverse event > 90 days after the radiation therapy completion date. ] [ Designated as safety issue: Yes ]
  • Comparison of disease-specific health related quality of life (HRQOL) change by EPIC, Hopkins Verbal Learning Test Revised (HVLT-R), Trail Making Test, parts A & B, and Controlled Oral Word Association Test (COWAT) [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: No ]
  • Assessment of mood and depression change using QOL measured by the Hopkins Symptom Checklist (HSCL-25) [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: No ]
  • Assessment and comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY) [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: No ]
  • Evaluation and comparison of the cost-utility using EuroQoL - 5 Dimensions (EQ-5D) [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: No ]
  • Association between serum levels of beta-amyloid (Abeta) and measures of HSCL-25, the HVLT-R, Trail Making Test, parts A & B, or the COWAT [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: No ]
  • Prognostic value of genomic and proteomic markers for the primary and secondary clinical endpoints [ Time Frame: Date of randomization to timepoint of the respective primary or secondary endpoint. ] [ Designated as safety issue: No ]
  • Assessment of the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity (Adverse Event terms: Urinary frequency/urgency) using the CTCAE v. 3.0 grading system [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1764
Study Start Date: February 2008
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Radiation: radiation therapy
Once daily, 5 days a week
Experimental: 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 (AA) and LHRH agonist therapy, for a total of 4-6 months. Patients receive AA 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 AA 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.
Drug: bicalutamide
Oral, daily
Drug: flutamide
Oral, daily
Radiation: radiation therapy
Once daily, 5 days a week
Experimental: 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).
Drug: bicalutamide
Oral, daily
Drug: flutamide
Oral, daily
Radiation: radiation therapy
Once daily, 5 days a week

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567580

  Show 460 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Cancer and Leukemia Group B
NRG Oncology Foundation, Inc.
Investigators
Principal Investigator: Alan Pollack, MD, PhD Fox Chase Cancer Center
Study Chair: Leonard G. Gomella, MD Jefferson Medical College of Thomas Jefferson University
Study Chair: Joycelyn L. Speight, MD, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00567580     History of Changes
Obsolete Identifiers: NCT01312974
Other Study ID Numbers: RTOG 0534, CDR0000577574, NCI-2009-00733
Study First Received: December 4, 2007
Last Updated: July 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Flutamide
Bicalutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014