NCT00567580|Active Not RecruitingPhase 3ResultsDMC

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

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

Radiation Therapy Oncology Group ClinicalTrials.gov

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3 other identifiers

RTOG-0534CDR0000577574NCI-2009-00733

Study Type

interventional

Target

1,792

Locations

4 countries

Sites

460

Timeline

RegisteredDec 2007

StartedFeb 2008

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,792

participants targeted

Target at P75+ for phase_3 prostate-cancer

Geographic Reach

4 countries

460 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed

2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed

10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

March 2, 2021

Completed

Last Updated

May 9, 2025

Status Verified

May 1, 2024

Enrollment Period

10.4 years

First QC Date

December 4, 2007

Results QC Date

February 1, 2021

Last Update Submit

May 1, 2025

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancerstage IIA prostate cancerstage III prostate canceradenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Free From Progression (FFP) at 5 Years
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.
From randomization to five years.

Secondary Outcomes (14)

Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure)
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)
From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants With Local Failure
From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants With Distant Metastasis
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)
From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
+9 more secondary outcomes

Study Arms (3)

PBRT Alone

ACTIVE COMPARATOR

Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.

Radiation: PBRT

PBRT + STAD

EXPERIMENTAL

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).

Radiation: PBRTDrug: AADrug: LHRH agonist

PLNRT + PBRT + STADT

EXPERIMENTAL

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).

Radiation: PBRTRadiation: PLNRTDrug: AADrug: LHRH agonist

Interventions

PBRTRADIATION

1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required.

Also known as: Prostate bed radiotherapy, Three-Dimensional Conformal Radiation Therapy (3D-CRT), Intensity modulated RT (IMRT)

PBRT + STADPBRT AlonePLNRT + PBRT + STADT

PLNRTRADIATION

1.8 Gy per fraction once daily, 5 days a week, totaling 45 Gy. 3D-CRT or IMRT required.

Also known as: Pelvic lymph node radiotherapy

PLNRT + PBRT + STADT

AADRUG

Antiandrogen (AA) therapy can be either 250 mg flutamide by mouth three times a day or 50 mg bicalutamide by mouth once a day.

Also known as: flutamide, bicalutamide

PBRT + STADPLNRT + PBRT + STADT

LHRH agonistDRUG

Luteinizing hormone-releasing hormone (LHRH) agonist can be any analog approved by the FDA (or by Health Canada for Canadian institutions) and may be given in any possible combination such that the total LHRH treatment time is 4-6 months. LHRH analogs are administered with a variety of techniques, including subcutaneous insertion of a solid plug in the abdominal wall, intramuscular injection, and subcutaneous injection.

Also known as: leuprolide, goserelin, buserelin, triptorelin

PBRT + STADPLNRT + PBRT + STADT

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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;
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;
Prostatectomy Gleason score of 9 or less;
Zubrod Performance Status of 0-1;
Age ≥ 18;
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.
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);
+4 more criteria

You may not qualify if:

A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
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;
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;
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);
Neoadjuvant chemotherapy before or after prostatectomy;
Prior chemotherapy for any other disease site if given within 5 years prior to registration;
Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;
Prior pelvic radiotherapy;
Prior invasive malignancy (except non-melanomatous skin cancer) or superficial bladder cancer unless disease free for a minimum of 5 years \[for example, carcinoma in situ of the oral cavity is permissible\];
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;
+4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Radiation Therapy Oncology Grouplead
National Cancer Institute (NCI)collaborator
Cancer and Leukemia Group Bcollaborator
NRG Oncologycollaborator

Study Sites (460)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

Arizona Center for Cancer Care - Peoria

Peoria, Arizona, 85381, United States

Location

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Arizona Oncology - Tucson

Tucson, Arizona, 85704, United States

Location

Auburn Radiation Oncology

Auburn, California, 95603, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Radiation Oncology Centers - Cameron Park

Cameron Park, California, 95682, United States

Location

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Enloe Cancer Center at Enloe Medical Center

Chico, California, 95926, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Washington Township Hospital

Fremont, California, 94538, United States

Location

California Cancer Center - Woodward Park Office

Fresno, California, 93720, United States

Location

Cancer Care Associates

Fresno, California, 93720, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Providence Holy Cross Cancer Center

Mission Hills, California, 91346-9600, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Sutter Health - Western Division Cancer Research Group

Novato, California, 94945, United States

Location

Alta Bates Summit Medical Center - Summit Campus