Prostate CancerPhase 2NCT00450411
Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy
A Phase 2 study testing 125-Iodine and 103-palladium in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 17 sites in 2 countries.
Trial summary
RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously… Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 125-Iodine and 103-palladium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 17 sitesin 2 countries
- Study dates
- May 2007to 20 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-documented locally recurrent prostatic adenocarcinoma > 30 months after the completion of EBRT, biopsied ≤ 180 days prior to registration and confirmed by central pathology review
- Disease-related characteristics at initial diagnosis (i.e., prior to EBRT) that fit the following criteria: Stages T1-T2c, Gleason scores 2-7, and PSA ≤ 20 ng/mL
- Staging, performed within 8 weeks prior to registration:
- 3.1 History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen)
- 3.2 Negative lymph nodes by imaging (pelvic ± abdominal CT or MR), or by nodal dissection (laparoscopy or laparotomy)
- 3.3 No evidence of bone metastases (M0) on bone scan
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- Zubrod Performance Scale 0-1
- American Urological Association Symptom Index Score (AUA BPH) < 15 (Note: The use of alpha blockers is permitted when evaluating lower urinary tract symptoms, i.e., the AUA score with the patient on alpha blockers is acceptable)
- Age ≥ 18
- Baseline serum prostate-specific antigen (PSA) value < 10 ng/mL performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 8 weeks prior to registration. PSA should not be performed within 10 days of a prior prostate biopsy, and if the patient has been started on hormonal therapy, the PSA should be performed within 8 weeks prior to the commencement of hormonal therapy.
- Prostate volume as measured by transrectal ultrasound (TRUS) ≤ 45 cc or pubic arch interference ruled out
- The patient must be suitable for spinal or general anesthesia
- The patient must sign a study-specific informed consent form before study entry
Who cannot join
- Prior invasive (except non-melanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for a minimum of 3 years. Previous diagnosis of low-grade lymphoma or chronic lymphocytic leukemia is allowed.
- Prior EBRT to the prostate such that the minimum dose to the prostate exceeded 78 Gy (2 Gy fractions) or 79.8 Gy (1.9 Gy fractions) or 81 Gy (1.8 Gy fractions)
- Baseline gastrointestinal (GI) or genitourinary (GU) toxicity (for any reason) grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
- Severe, active co-morbidity, defined as follows:
- 4.1 Unstable angina and/or decompensated congestive heart failure
- 4.2 Myocardial infarction within the last 6 months
Show all 21Show fewer
- 4.3 Bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- 4.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- 4.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- 4.6 Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
- Clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis (i.e., prior to EBRT) or at time of local recurrence (i.e., prior to study registration)
- ° 5.1 Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1)
- Any of the following prior therapies:
- Transurethral resection of the prostate (TURP)
- Radionuclide (permanent or temporary implantation) prostate brachytherapy
- Prostatectomy or prostatic cryosurgery
- High-intensity focused ultrasound (HIFU)
- Bilateral orchiectomy
- Chemotherapy for prostatic carcinoma
- NOTE 1: Androgen suppression therapy is permissible provided that the luteinizing hormone-releasing hormone (LHRH) agonist was started at least 2 months and no more than 6 months before registration.
- NOTE 2: Any combination of neoadjuvant, concurrent, or adjuvant androgen suppression therapy at the time of initial external radiotherapy is permissible provided the total duration was ≤ 8 months. If > 8 months, evidence of a normal serum testosterone must be documented.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States13 sites
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
City of Saint Peters, Missouri, 63376
California Cancer Center - Woodward Park Office
Fresno, California, 93720
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013
Robinson Radiation Oncology
Ravenna, Ohio, 44266
Cancer Institute at St. John's Hospital
Springfield, Illinois, 62702
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Flower Hospital Cancer Center
Sylvania, Ohio, 43560
West Allis Memorial Hospital
West Allis, Wisconsin, 53227
Canada4 sites
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, T6G 1Z2
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Odette Cancer Centre at Sunnybrook
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously treated with external-beam radiation therapy.
Read the detailed description
OBJECTIVES:
Primary
- Determine the late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events in patients with locally recurrent adenocarcinoma of the prostate previously treated with external-beam radiotherapy who are currently receiving transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.
Secondary
- Determine the acute treatment-related GI and GU adverse events in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the disease-free survival of patients treated with this regimen.
- Determine the disease-specific survival of patients treated with this regimen.
- Determine clinical patterns of tumor recurrence (time to local tumor progression or distant failure) in patients treated with this regimen.
- Determine the time to biochemical failure in patients treated with this regimen.
- Determine the post-brachytherapy dosimetric coverage in patients treated with this regimen.
OUTLINE: This is a prospective, multicenter study.
Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- 125-Iodine, 103-palladium
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
125-IodineRadiation
Also called brachytherapy
Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy
103-palladiumRadiation
Also called brachytherapy
Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy
| Study group | Role | What they receive |
|---|---|---|
| Brachytherapy | Experimental | Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103) Receives: Radiation: 125-Iodine; Radiation: 103-palladium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, late treatment-related adverse events were evaluated between 271 days and 730 days from the implant.
Measured: Between 271 days and 730 days from date of implantation
Secondary outcomes (7)
Number of Patients With Acute Treatment-related GI and GU Adverse Events
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, acute treatment-related adverse events will be evaluated within 270 days from the implant.
Measured: From date of implantation to 270 days
Percentage of Participants Alive at 5 Years (Overall Survival)
Survival time is defined as time from registration to date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all patients were potentially observed for at least 5 years from registration.
Measured: From registration to 5 years
Percentage of Participants Alive Without Disease (Disease-free Survival)
An event for disease-free survival is defined as local progression, distant progression, biochemical failure, initiation of salvage hormone therapy, or death due to any cause.Biochemical failure is defined as a rise in prostate-specific antigen (PSA) by at least 2 ng/mL over the current nadir. Local progression is defined as documented progressive disease on digital rectal examination or a post-implant prostate biopsy showing carcinoma. Distant progression is defined as documented lymphatic or hematogenous metastatic disease. Disease-free survival time is defined as time from registration to the date of first event or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.
Measured: From registration to 5 years
Percentage of Participants With Prostate Cancer Death at 5 Years (Disease-specific Survival)
An event for prostate cancer death is defined as any of the following: primary cause of death certified as due to prostate cancer, death associated with tumor progression occurring after initiation of salvage anti-tumor therapy, death associated with a rise in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy, death associated with disease progression in the absence of any anti-tumor therapy, or death from a complication of protocol therapy irrespective of disease status. Time to prostate cancer death is defined as time from registration to date of first event, last known follow-up (censored), or death unrelated to prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.
Measured: From registration to 5 years
Percentage of Participants With Local Failure at 5 Years
Local progression is defined as documented progressive disease on digital rectal examination or a post-implant prostate biopsy showing carcinoma. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Analysis occurred after all patients were potentially observed for at least 5 years from registration.
Measured: From registration to 5 years
Percentage of Participants With Distant Failure at 5 Years
Distant failure is defined as documented lymphatic or hematogenous metastatic disease. Time to distant failure is defined as time from registration to the date of first distant failure, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated using the cumulative incidence method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.
Measured: From registration to 5 years
Percentage of Participants With Biochemical Failure at 4 Years
Biochemical failure is defined as PSA 2 ng/ml or more higher than the nadir PSA value, or initiation of hormone therapy at any time after brachytherapy. (If the PSA rise is within 36 months following brachytherapy and is followed by a subsequent non-hormonal induced PSA decrease, the patient will not be considered as a failure.) Time to biochemical failure is defined as time from registration to the date of first biochemical failure, last known follow-up (censored), or death without local recurrence (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.
Measured: From registration to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2016
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Juanita M. Crook, MD, Study chair, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450411
- Sponsor's protocol ID
- RTOG-0526
- Other IDs
- CDR0000533887
- Status last verified
- May 2022
- First submitted
- 20 Mar 2007
- Last updated
- 21 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Crook J, Rodgers JP, Pisansky TM, Trabulsi EJ, Amin MB, Bice W, Morton G, Murtha AD, Vigneault E, Helou J, Michalski JM, Roach M 3rd, Beyer D, Jani AB, Horwitz EM, Raben A, Pugh S, Sandler H. Salvage Low-Dose-Rate Prostate Brachytherapy: Clinical Outcomes of a Phase 2 Trial for Local Recurrence after External Beam Radiation Therapy (NRG Oncology/RTOG 0526). Int J Radiat Oncol Biol Phys. 2022 Apr 1;112(5):1115-1122. doi: 10.1016/j.ijrobp.2021.10.138. Epub 2021 Nov 3.
PubMed 34740768Crook JM, Zhang P, Pisansky TM, Trabulsi EJ, Amin MB, Bice W, Morton G, Pervez N, Vigneault E, Catton C, Michalski J, Roach M 3rd, Beyer D, Jani A, Horwitz E, Donavanik V, Sandler H. A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer After External Beam Radiation Therapy (NRG Oncology/RTOG-0526). Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):335-343. doi: 10.1016/j.ijrobp.2018.09.039. Epub 2018 Oct 9.
PubMed 30312717
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
- ClinicalTrials.gov ID
- NCT00450411
- Acronym / sponsor ID
- RTOG-0526
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Study start
- May 2007
- Primary completion
- Jun 2016 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Posted 7 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously treated with external-beam radiation therapy.
Detailed description
OBJECTIVES:
Primary
- Determine the late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events in patients with locally recurrent adenocarcinoma of the prostate previously treated with external-beam radiotherapy who are currently receiving transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.
Secondary
- Determine the acute treatment-related GI and GU adverse events in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the disease-free survival of patients treated with this regimen.
- Determine the disease-specific survival of patients treated with this regimen.
- Determine clinical patterns of tumor recurrence (time to local tumor progression or distant failure) in patients treated with this regimen.
- Determine the time to biochemical failure in patients treated with this regimen.
- Determine the post-brachytherapy dosimetric coverage in patients treated with this regimen.
OUTLINE: This is a prospective, multicenter study.
Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brachytherapy | Experimental | Radiation: 125-Iodine, Radiation: 103-palladiumProstate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Biopsy-documented locally recurrent prostatic adenocarcinoma > 30 months after the completion of EBRT, biopsied ≤ 180 days prior to registration and confirmed by central pathology review
- Disease-related characteristics at initial diagnosis (i.e., prior to EBRT) that fit the following criteria: Stages T1-T2c, Gleason scores 2-7, and PSA ≤ 20 ng/mL
- Staging, performed within 8 weeks prior to registration:
- Zubrod Performance Scale 0-1
- American Urological Association Symptom Index Score (AUA BPH) < 15 (Note: The use of alpha blockers is permitted when evaluating lower urinary tract symptoms, i.e., the AUA score with the patient on alpha blockers is acceptable)
Key exclusion criteria (21 listed)
- Prior invasive (except non-melanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for a minimum of 3 years. Previous diagnosis of low-grade lymphoma or chronic lymphocytic leukemia is allowed.
- Prior EBRT to the prostate such that the minimum dose to the prostate exceeded 78 Gy (2 Gy fractions) or 79.8 Gy (1.9 Gy fractions) or 81 Gy (1.8 Gy fractions)
- Baseline gastrointestinal (GI) or genitourinary (GU) toxicity (for any reason) grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
- Severe, active co-morbidity, defined as follows:
- Clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis (i.e., prior to EBRT) or at time of local recurrence (i.e., prior to study registration)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 125-IodineAlso: brachytherapyBrachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy | Radiation | Brachytherapy |
| 103-palladiumAlso: brachytherapyBrachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy | Radiation | Brachytherapy |
Primary outcome
Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)
Time frame: Between 271 days and 730 days from date of implantation
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, late treatment-related adverse events were evaluated between 271 days and 730 days from the implant.
7 secondary outcomes
Number of Patients With Acute Treatment-related GI and GU Adverse Events
Time frame: From date of implantation to 270 days
Percentage of Participants Alive at 5 Years (Overall Survival)
Time frame: From registration to 5 years
Percentage of Participants Alive Without Disease (Disease-free Survival)
Time frame: From registration to 5 years
Percentage of Participants With Prostate Cancer Death at 5 Years (Disease-specific Survival)
Time frame: From registration to 5 years
Percentage of Participants With Local Failure at 5 Years
Time frame: From registration to 5 years
Percentage of Participants With Distant Failure at 5 Years
Time frame: From registration to 5 years
Percentage of Participants With Biochemical Failure at 4 Years
Time frame: From registration to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34740768Crook J, Rodgers JP, Pisansky TM, Trabulsi EJ, Amin MB, Bice W, Morton G, Murtha AD, Vigneault E, Helou J, Michalski JM, Roach M 3rd, Beyer D, Jani AB, Horwitz EM, Raben A, Pugh S, Sandler H. Salvage Low-Dose-Rate Prostate Brachytherapy: Clinical Outcomes of a Phase 2 Trial for Local Recurrence after External Beam Radiation Therapy (NRG Oncology/RTOG 0526). Int J Radiat Oncol Biol Phys. 2022 Apr 1;112(5):1115-1122. doi: 10.1016/j.ijrobp.2021.10.138. Epub 2021 Nov 3.
- Derived from this study: PubMed 30312717Crook JM, Zhang P, Pisansky TM, Trabulsi EJ, Amin MB, Bice W, Morton G, Pervez N, Vigneault E, Catton C, Michalski J, Roach M 3rd, Beyer D, Jani A, Horwitz E, Donavanik V, Sandler H. A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer After External Beam Radiation Therapy (NRG Oncology/RTOG-0526). Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):335-343. doi: 10.1016/j.ijrobp.2018.09.039. Epub 2018 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juanita M. Crook, MD study chair
British Columbia Cancer Agency
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 125-Iodine and 103-palladium in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) (time frame: Between 271 days and 730 days from date of implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00450411, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.