Prostate CancerPhase 2NCT00551525
Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer
A Phase 2 study testing Radiotherapy and Samarium 153 in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 29 sites in United States.
Trial summary
RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after radical prostatectomy for prostate cancer. 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?
- Radiotherapy and Samarium 153
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 29 sitesUnited States
- Study dates
- Apr 2008to Dec 2016
- 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
- Histologically proven diagnosis of prostate cancer progressing after prior radical prostatectomy as indicated by one of the following:
- Postoperative prostate-specific antigen (PSA) rising above 1.0 ng/mL
- Postoperative PSA rising above 0.2 ng/mL with a surgical tumor Gleason score of 9 or 10
- Postoperative PSA rising above 0.2 ng/ml with nodal disease
- Stage II-IV disease (T2 -T4, N0-N1)
- No distant metastases based on the following minimum diagnostic work up:
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- History or physical examination within the past 8 weeks
- Bone scan negative for bone metastases within the past 4 months
- Abdominal imaging negative for metastases within the past 6 months
- Zubrod Performance Status 0-1
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm³
- Platelet count ≥ 100,000 cells/mm³
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is permitted)
Who cannot join
- Biopsy evidence of M1 disease
- Presence of neuroendocrine features in any prostate cancer specimen
- PATIENT CHARACTERISTICS:
- Prior invasive malignancy (except nonmelanoma skin cancer) unless disease free for a minimum of 3 years
- Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
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- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (laboratory tests for liver function and coagulation parameters, however, are not required for entry into this protocol)
- Renal failure (laboratory tests for renal function, however, are not required for entry into this protocol)
- AIDS based upon current Centers for Disease Control (CDC) definition (HIV testing is not required)
- PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy for the study cancer
- Prior chemotherapy for a different cancer is permitted
- No hormonal therapy initiated within the last 3 months
- No prior radiotherapy to the pelvic region that would result in overlap of radiotherapy fields
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, 71315-3198
Auburn Radiation Oncology
Auburn, California, 95603
Barberton Citizens Hospital
Barberton, Ohio, 44203
Billings Clinic - Downtown
Billings, Montana, 59107-7000
Radiation Oncology Centers - Cameron Park
Cameron Park, California, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, 95608
John B. Amos Cancer Center
Columbus, Georgia, 31904
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, 02721
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0232
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, 90027
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581
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
Radiation Oncology Center - Roseville
Roseville, California, 95661
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, 95815
University of California Davis Cancer Center
Sacramento, California, 95817
Mercy General Hospital
Sacramento, California, 95819
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141
Stony Brook University Cancer Center
Stony Brook, New York, 11794-9446
Solano Radiation Oncology Center
Vacaville, California, 95687
Coastal Cancer Center at Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, 23454
About this study
Official title: A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy
RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after radical prostatectomy for prostate cancer.
PURPOSE: This phase II trial is studying how well samarium Sm 153 lexidronam pentasodium and 3-D conformal radiation therapy or intensity-modulated radiation therapy work in treating patients with rising PSA levels after radical prostatectomy for prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess the effectiveness of samarium Sm 153 lexidronam pentasodium (as determined by a 30% decline in the PSA level within 12 weeks) followed by either three-dimensional conformal radiation therapy or intensity-modulated radiation therapy in patients with rising prostate-specific antigen levels (PSA) after radical prostatectomy prostate cancer.
Secondary
- To assess the proportion of patients completing protocol treatment.
- To evaluate hematological toxicity at 12 weeks.
- To evaluate samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks.
- To evaluate the "acute" and "late" radiation therapy-related events having occurred up to 24 weeks from the end of radiation therapy.
- To compare the freedom from progression rate at 2 years to that predicted by the Kattan Nomograms.
OUTLINE: Patients receive samarium Sm 153 lexidronam pentasodium (SM) IV on day 1. Patients are closely monitored for prostate-specific antigen (PSA) level and SM-associated toxicity for 12 weeks. After the 12 weeks, patients undergo either intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 7-8 weeks. Patients may receive hormonal therapy (after radiation therapy) at the discretion of their physician.
Treatment continues in the absence of disease progression (defined as a PSA doubling time less than 3 months), severe thrombocytopenia (defined as a platelet count of 25,000 cells/mm³ or less), or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months, 6 months, and 12 months, every 6 months for 2 years, and then annually thereafter.
- Conditions
- Prostate Cancer
- Being tested
- Radiotherapy, Samarium 153
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV 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.
RadiotherapyRadiation
Also called 3D-CRT, IMRT, Intensity-modulated radiation therapy
3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa begins 12 weeks (+/- 1 week) after Samarium 153 administration. Daily tumor doses of 1.8 - 2.0 Gy per day, 5 days per week x 7-8 weeks.
Samarium 153Drug
Also called Samarium sm 153 lexidronam pentasodium, Quadramet
Samarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy + Samarium 153 | Experimental | Samarium 153 infusion followed by radiotherapy 12 weeks later Receives: Radiation: Radiotherapy; Drug: Samarium 153 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration
A PSA response for each patient is calculated by (baseline PSA-current PSA)/baseline PSA. A decline of at least 30% is considered a response. Null hypothesis (H0): Samarium 153 is not effective (pt ≤ 0.1) vs alternative hypothesis (HA): Samarium 153 is effective (pt ≥ 0.25). The sample size of 69 analyzable patients (eligible patients receiving any protocol treatment with ≥ 12 weeks follow-up from the Samarium 153 injection) was calculated based on Fleming's Multiple Testing Procedure at a significance level of 0.019 and 91% statistical power requiring 69 patients to conclude either the null or alternative hypotheses. With only 52 analyzable patients this study had only 78% power and needed at least 11 patients with a PSA response to reject H0.
Measured: Twelve weeks from the date of Samarium 153 infusion.
Secondary outcomes (5)
Completion of Therapy
The completion of protocol treatment is defined as receiving at least 64.8 Gy radiation after the Samarium 153 injection. The null hypothesis that the proportion of the number of patients who complete the protocol treatment (the Samarium 153 and the radiation therapy) is less than or equal to 0.5 was tested using an exact test for a binomial proportion. If the true treatment completion proportion is 0.8, then the statistical power of a one-sided 0.378 level exact binomial test of proportion would be 94.1% with the sample size of 26. Therefore any number of analyzable patients greater than 26 patients provides enough power for this endpoint.
Measured: 90 days from the end of radiation therapy.
Number of Patients With Hematologic Toxicity at 12 Weeks
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. Hematological toxicities consist of platelet grade 3-5, white blood cell grade 3-5, hemoglobin grade 3-5, and any secondary leukemia's.
Measured: Twelve weeks from the date of Samarium 153 infusion.
Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)
Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. The treatment-related attribution includes definitely, probably or possibly related to treatment. The treatment-related adverse events are:
- HEMATOLOGIC Platelet grade 3-5 White blood cell count (WBC) grade 3-5 Hemoglobin grade 3-5 Any secondary leukemia's
- HEMORRHAGE/BLEEDING Hemorrhage, gastrointestinal - anus, rectum grade 3-5 Hemorrhage, genitourinary - bladder, prostate, urethra grade 3-5
- SAMARIUM 153-RELATED GRADE 5 ADVERSE EVENT PRIOR TO TREATMENT OF RADIATION.
Measured: Twelve weeks from the date of Samarium 153 infusion
Acute and Late Radiotherapy-Related Adverse Events
The number of patients who experienced a grade 1-5 radiation-related adverse events within 90 days of the start of radiotherapy (acute) and after 90 days (late). Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. Multivariate logistic regression was used to model the association of clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, Gleason score (<8 vs. 8-10[reference level]), and age with the occurrence of any acute radiotherapy-related adverse event. Odds ratios and the respective 95% confidence intervals were computed for each factor. Per the protocol, late adverse events were not analyzed.
Measured: 90 days from start of radiotherapy
Freedom From Progression (FFP) Rate at 2 Years
Progression is defined as biochemical (PSA) failure at any time for 2 years after prostatic fossa radiation therapy (RT), initiation of systemic therapy, or clinical failure. Biochemical failure is defined as a rise of 0.2 ng/ml or more above the nadir PSA after completion of RT followed by another higher value, or a continued rise in the serum PSA despite RT. FFP rate at 2 years was to be compared to that predicted by the Kattan Nomograms. See "Limitations and Caveats" section.
Measured: From randomization to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startApr 2008
- Primary completionJul 2014
- Study completionDec 2016
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.
- 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
- 67 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
- Richard K. Valicenti, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityOliver Sartor, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551525
- Sponsor's protocol ID
- RTOG-0622
- Other IDs
- CDR0000570622, NCI-2009-01094
- Status last verified
- Jun 2017
- First submitted
- 30 Oct 2007
- Last updated
- 25 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00551525
- Acronym / sponsor ID
- RTOG-0622
- Conditions
- Prostate Cancer
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Study start
- Apr 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Posted 25 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after radical prostatectomy for prostate cancer.
PURPOSE: This phase II trial is studying how well samarium Sm 153 lexidronam pentasodium and 3-D conformal radiation therapy or intensity-modulated radiation therapy work in treating patients with rising PSA levels after radical prostatectomy for prostate cancer.
Detailed description
OBJECTIVES:
Primary
- To assess the effectiveness of samarium Sm 153 lexidronam pentasodium (as determined by a 30% decline in the PSA level within 12 weeks) followed by either three-dimensional conformal radiation therapy or intensity-modulated radiation therapy in patients with rising prostate-specific antigen levels (PSA) after radical prostatectomy prostate cancer.
Secondary
- To assess the proportion of patients completing protocol treatment.
- To evaluate hematological toxicity at 12 weeks.
- To evaluate samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks.
- To evaluate the "acute" and "late" radiation therapy-related events having occurred up to 24 weeks from the end of radiation therapy.
- To compare the freedom from progression rate at 2 years to that predicted by the Kattan Nomograms.
OUTLINE: Patients receive samarium Sm 153 lexidronam pentasodium (SM) IV on day 1. Patients are closely monitored for prostate-specific antigen (PSA) level and SM-associated toxicity for 12 weeks. After the 12 weeks, patients undergo either intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 7-8 weeks. Patients may receive hormonal therapy (after radiation therapy) at the discretion of their physician.
Treatment continues in the absence of disease progression (defined as a PSA doubling time less than 3 months), severe thrombocytopenia (defined as a platelet count of 25,000 cells/mm³ or less), or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months, 6 months, and 12 months, every 6 months for 2 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy + Samarium 153 | Experimental | Radiation: Radiotherapy, Drug: Samarium 153Samarium 153 infusion followed by radiotherapy 12 weeks later |
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)
- Histologically proven diagnosis of prostate cancer progressing after prior radical prostatectomy as indicated by one of the following:
- Stage II-IV disease (T2 -T4, N0-N1)
- No distant metastases based on the following minimum diagnostic work up:
- Zubrod Performance Status 0-1
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm³
Key exclusion criteria (16 listed)
- Biopsy evidence of M1 disease
- Presence of neuroendocrine features in any prostate cancer specimen
- Prior invasive malignancy (except nonmelanoma skin cancer) unless disease free for a minimum of 3 years
- Severe, active comorbidity, defined as follows:
- No prior systemic chemotherapy for the study cancer
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 |
|---|---|---|
| RadiotherapyAlso: 3D-CRT, IMRT, Intensity-modulated radiation therapy3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa begins 12 weeks (+/- 1 week) after Samarium 153 administration. Daily tumor doses of 1.8 - 2.0 Gy per day, 5 days per week x 7-8 weeks. | Radiation | Radiotherapy + Samarium 153 |
| Samarium 153Also: Samarium sm 153 lexidronam pentasodium, QuadrametSamarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration. | Drug | Radiotherapy + Samarium 153 |
Primary outcome
Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration
Time frame: Twelve weeks from the date of Samarium 153 infusion.
A PSA response for each patient is calculated by (baseline PSA-current PSA)/baseline PSA. A decline of at least 30% is considered a response. Null hypothesis (H0): Samarium 153 is not effective (pt ≤ 0.1) vs alternative hypothesis (HA): Samarium 153 is effective (pt ≥ 0.25). The sample size of 69 analyzable patients (eligible patients receiving any protocol treatment with ≥ 12 weeks follow-up from the Samarium 153 injection) was calculated based on Fleming's Multiple Testing Procedure at a significance level of 0.019 and 91% statistical power requiring 69 patients to conclude either the null or alternative hypotheses. With only 52 analyzable patients this study had only 78% power and needed at least 11 patients with a PSA response to reject H0.
5 secondary outcomes
Completion of Therapy
Time frame: 90 days from the end of radiation therapy.
Number of Patients With Hematologic Toxicity at 12 Weeks
Time frame: Twelve weeks from the date of Samarium 153 infusion.
Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)
Time frame: Twelve weeks from the date of Samarium 153 infusion
Acute and Late Radiotherapy-Related Adverse Events
Time frame: 90 days from start of radiotherapy
Freedom From Progression (FFP) Rate at 2 Years
Time frame: From randomization to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard K. Valicenti, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Oliver Sartor, MD study chair
Dana-Farber Cancer Institute
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy and Samarium 153 in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 29 sites in United States.
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 16 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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 25 Jul 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?
Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration (time frame: Twelve weeks from the date of Samarium 153 infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2017.