Primary outcomeNumber· From randomization to five years.
Percentage of Participants Free From Progression (FFP) at 5 Years
| Group | Value (percentage of participants) |
|---|---|
| PBRT Alone | 70.3 |
| PBRT + STAD | 81.3 |
| PLNRT + PBRT + STAD | 87.4 |
Trial · Interventional
Status unknownPhase 3Results postedRegistry dataProstate 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
NCTNCT00567580 (opens ClinicalTrials.gov in a new tab)Other idRTOG-0534Other idCDR0000577574Other idNCI-2009-00733
Overview
- Status
- Status unknown
- Phase
- Phase 3
- Enrollment
- 1,792 participants (actual)
- Sponsor
- Radiation Therapy Oncology Group · Network
- Design
- Randomized · Open label (no masking)
- Countries
4 countries
United States, Canada, China, Israel
- Start
- Feb 2008
- Primary completion
- 12 Jul 2018
- Completion
- Not stated
- First posted
- 5 Dec 2007 (estimated)
- Last update posted
- 9 May 2025
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820102012201420162018
- Ph 3
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
NCT00567580Feb 2008 to 12 Jul 2018 (primary)
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- PBRTRadiation
- PLNRTRadiation
- AADrug
- LHRH agonistDrug
Arms3
Active comparator
PBRT Alone
Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
Experimental
PBRT + STAD
Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Experimental
PLNRT + PBRT + STADT
Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of Participants Free From Progression (FFP) at 5 Years
Time frame · From randomization to five years.
Registry description
Progression is defined as the first occurrence of the following events: biochemical failure by the Phoenix definition (prostate-specific antigen \[PSA\] ≥ 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant), or death from any cause. The initiation of second salvage therapy before progression was a protocol violation and resulted in censoring. Progression time is defined as time from randomization to the date of progression, second salvage therapy (censored), or last known follow-up (censored). Freedom from progression rates are estimated using the Kaplan-Meier method. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.
Secondary outcomes(14)
Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure)
Time frame · From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Registry description
Secondary biochemical (failure) is defined as either of two occurrences: 1. For detectable post-baseline PSA values (≥ 0.1), the first occurrence of a PSA value that is both ≥ 0.4 and a second rise above nadir; 2.The start of second salvage therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.
Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease)
Time frame · From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Registry description
Hormone-refractory disease (failure) is defined as three rises in PSA after the start of second salvage androgen deprivation therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Percentage of Participants With Local Failure
Time frame · From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Registry description
Local failure is defined as first occurrence of local clinical progression. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Percentage of Participants With Distant Metastasis
Time frame · From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Registry description
Distant metastasis (failure) is defined as the occurrence of distant metastasis determined by imaging. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality)
Time frame · From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Registry description
Cause-specific mortality (failure) is defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), or death following disease progression (clinical or biochemical) in the absence of or after the initiation of any salvage therapy. \[Biochemical progression is indicated by any rise in PSA.\] Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Percentage of Participants Alive (Overall Mortality)
Time frame · From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Registry description
Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. Pairwise comparisons of the overall distributions of failure times are reported in statistical analysis section, with five-year rates reported here. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT)
Time frame · From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks).
Registry description
Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Pairwise comparisons of Arm 2 vs Arm 1 and Arm 3 vs. Arm 2 are reported in the statistical analysis.
Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT)
Time frame · AE: from 91 days after completion of RT (approximately 7-8 weeks) to last follow-up. Vital status: from randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Registry description
Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Late adverse events (AE) are defined as occurring \> 90 days from the completion of RT. Failure time is defined as time from randomization to the date of first late grade 2 or grade 3 adverse event, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times between Arm 2 and Arm 1 and between Arm 3 and Arm 2, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored.
Comparison of Disease-specific Health Related Quality of Life (HRQOL) Change by the Expanded Prostate Cancer Index Composite (EPIC), Hopkins Verbal Learning Test Revised (HVLT-R), Trail Making Test A & B, and Controlled Oral Word Association Test (COWAT)
Time frame · From the 6th week of radiation therapy to 5 years post radiation therapy.
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.
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.
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.
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.
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure)
| Group | Value (percentage of participants) |
|---|---|
| PBRT Alone | 35.7 |
| PBRT + STAD | 22.3 |
| PLNRT + PBRT + STAD | 14.5 |
Secondary outcomeNumber· From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease)
| Group | Value (percentage of participants) |
|---|---|
| PBRT Alone | 2.9 |
| PBRT + STAD | 2.4 |
| PLNRT + PBRT + STAD | 1.2 |
Secondary outcomeNumber· From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants With Local Failure
| Group | Value (percentage of participants) |
|---|---|
| PBRT Alone | 3.1 |
| PBRT + STAD | 1.2 |
| PLNRT + PBRT + STAD | 0.4 |
Secondary outcomeNumber· From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants With Distant Metastasis
| Group | Value (percentage of participants) |
|---|---|
| PBRT Alone | 8.3 |
| PBRT + STAD | 5.9 |
| PLNRT + PBRT + STAD | 4.7 |
Secondary outcomeNumber· From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality)
| Group | Value (percentage of participants) |
|---|---|
| PBRT Alone | 2.7 |
| PBRT + STAD | 1.1 |
| PLNRT + PBRT + STAD | 0.8 |
Secondary outcomeNumber· From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants Alive (Overall Mortality)
| Group | Value (percentage of participants) |
|---|---|
| PBRT Alone | 93.9 |
| PBRT + STAD | 96.1 |
| PLNRT + PBRT + STAD | 95.7 |
Secondary outcomeNumber· From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks).
Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT)
| Group | Value (percentage of participants) |
|---|---|
| PBRT Alone | 18.8 |
| PBRT + STAD | 36.3 |
| PLNRT + PBRT + STAD | 43.6 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PBRT AloneProstate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | 48 / 547 | 18 / 547 | 433 / 547 |
| PBRT + STADTProstate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | 43 / 563 | 29 / 563 | 492 / 563 |
| PLNRT + PBRT + STADTPelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | 43 / 563 | 23 / 563 | 509 / 563 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedPollack A, Karrison TG, Balogh AG, Gomella LG, Low DA, Bruner DW, Wefel JS, Martin AG, Michalski JM, Angyalfi SJ, Lukka H, Faria SL, Rodrigues GB, Beauchemin MC, Lee RJ, Seaward SA, Allen AM, Monitto DC, Seiferheld W, Sartor O, Feng F, Sandler HM. The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial. Lancet. 2022 May 14;399(10338):1886-1901. doi: 10.1016/S0140-6736(21)01790-6. PMID 35569466
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. 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 (undissected pelvic lymph nodes \[Nx\]), i.e. lymph node dissection is not required;
• Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic or robotically assisted. There is no time limit for the date of radical prostatectomy.
2. A post-radical prostatectomy entry prostate-specific antigen (PSA) of ≥ 0.1 and \< 2.0 ng/mL at least 6 weeks (45 days) after prostatectomy and within 30 days of registration;
3. One of the following pathologic classifications:
* T3N0/Nx disease with or without a positive prostatectomy surgical margin; or
* T2N0/Nx disease with or without a positive prostatectomy surgical margin;
4. Prostatectomy Gleason score of 9 or less;
5. Zubrod Performance Status of 0-1;
6. Age ≥ 18;
7. No distant metastases, based upon the following minimum diagnostic workup:
* History/physical examination (including digital rectal exam) within 8 weeks (60 days) prior to registration;
* A computerized tomography (CT) scan of the pelvis (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to registration;
* Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis.
8. Adequate bone marrow function, within 90 days prior to registration, defined as follows:
* Platelets ≥ 100,000 cells/mm\^3 based upon compete blood count (CBC);
* Hemoglobin ≥ 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is recommended).
9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2 x the upper limit of normal within 90 days prior to registration;
10. Serum total testosterone must be ≥ 40% of the lower limit of normal (LLN) of the assay used (testosterone ÷ LLN must be ≥ 0.40) within 90 days prior to registration (Note: Patients who have had a unilateral orchiectomy are eligible as long as this requirement is met);
11. Patients must sign a study-specific informed consent prior to study entry.
Exclusion Criteria:
1. A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
2. 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 sampled and is negative;
3. Androgen deprivation therapy started prior to prostatectomy for \> 6 months (180 days) duration. Note: The use of finasteride or dutasteride (±tamsulosin) for longer periods prior to prostatectomy is acceptable;
4. Androgen deprivation therapy started after prostatectomy and prior to registration (Note: The use of finasteride or dutasteride (±tamsulosin) after prostatectomy is not acceptable - must be stopped within 3 months after prostatectomy. Androgen deprivation therapy must be stopped within 3 months after prostatectomy);
5. Neoadjuvant chemotherapy before or after prostatectomy;
6. Prior chemotherapy for any other disease site if given within 5 years prior to registration;
7. Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;
8. Prior pelvic radiotherapy;
9. Prior invasive malignancy (except non-melanomatous skin cancer) or superficial bladder cancer unless disease free for a minimum of 5 years \[for example, carcinoma in situ of the oral cavity is permissible\];
10. Severe, active co-morbidity, defined as follows:
* History of inflammatory bowel disease;
* History of hepatitis B or C; Blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis.
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
* Transmural myocardial infarction within the last 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; AST or ALT are required; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
* Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; Note, however, that human immunodeficiency viruses (HIV) testing is not required for entry into this protocol. The need to exclude patients with acquired immunodeficiency syndrome (AIDS) from this protocol is necessary because the treatments involved in this protocol may result in increased toxicity and immunosuppression.
11. Prior allergic reaction to the study drug(s) involved in this protocol.
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