Prostate CancerPhase 1NCT00328614
Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
A Phase 1 study testing Samarium-153, Total Androgen Suppression (TAS) with Bicalutamide and Total androgen suppression (TAS) with Goserelin Acetate in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Samarium-153, Total Androgen Suppression (TAS) with Bicalutamide and Total androgen suppression (TAS) with Goserelin Acetate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jun 2011
- Phase
- Phase 1
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSA 20-150 and Gleason score greater than or equal to 7 or clinical stage greater than or equal to T2, Gleason greater than or equal to 8, PSA less than or equal to 150
- Pathologically positive lymph nodes
- Pretreatment must be prior to study entry and prior to any hormonal therapy
- Zubrod 0-1
- Adequate hematologic function
Who cannot join
- Patients with PSA equal to or greater than 150
- Neuroendocrine features on histologic examination
- Radiologic evidence of metastatic disease
- Previous malignancy within last 5 years
- Prior pelvic radiation therapy or orchiectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer
The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.
Read the detailed description
The likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. Bone-targeted therapy, when given sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metastatic prostate cancer patients.
The use of Samarium-153 EDTMP in conjunction with hormonal therapy and external beam radiation therapy has never been previously evaluated in high risk clinically localized prostate cancer. Many patients with high-risk prostate cancer develop progressive disease within 2 years of therapy indicating that subclinical metastatic disease may be present at the time of initial diagnosis. In these high-risk patients, there may be a therapeutic benefit of combining hormonal therapy with external beam radiation therapy and Samarium-153 EDTMP to treat localized and subclinical bony disease, respectively.
- Conditions
- Prostate Cancer
- Being tested
- Samarium-153, Total Androgen Suppression (TAS) with Bicalutamide, Total androgen suppression (TAS) with Goserelin Acetate, Radiation Therapy
- Keywords
- Locally advanced prostate cancer, positive lymph nodes
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samarium-153Drug
Also called Samarium-153-ethylene diamine tetramethylene phosphonate, Samarium (153Sm) lexidronam, Quadramet
Samarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD).
Total Androgen Suppression (TAS) with BicalutamideDrug
Also called Casodex
Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.
Total androgen suppression (TAS) with Goserelin AcetateDrug
Also called Zoladex
Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.
Radiation TherapyDevice
Also called XRT, Radiotherapy
Radiation therapy will begin 3 months following the initiation of hormone administration. Daily tumor doses will be given 5 days per week for 7-8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Samarium-153 (0.25 mCi/kg) | Experimental | Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Receives: Drug: Samarium-153; Drug: Total Androgen Suppression (TAS) with Bicalutamide; Drug: Total androgen suppression (TAS) with Goserelin Acetate; Device: Radiation Therapy |
| Samarium-153 (0.5 mCi/kg) | Experimental | Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Receives: Drug: Samarium-153; Drug: Total Androgen Suppression (TAS) with Bicalutamide; Drug: Total androgen suppression (TAS) with Goserelin Acetate; Device: Radiation Therapy |
| Samarium-153 (0.75 mCi/kg) | Experimental | Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Receives: Drug: Samarium-153; Drug: Total Androgen Suppression (TAS) with Bicalutamide; Drug: Total androgen suppression (TAS) with Goserelin Acetate; Device: Radiation Therapy |
| Samarium-153 (1.0 mCi/kg) | Experimental | Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Receives: Drug: Samarium-153; Drug: Total Androgen Suppression (TAS) with Bicalutamide; Drug: Total androgen suppression (TAS) with Goserelin Acetate; Device: Radiation Therapy |
| Samarium-153 (1.5 mCi/kg) | Experimental | Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Receives: Drug: Samarium-153; Drug: Total Androgen Suppression (TAS) with Bicalutamide; Drug: Total androgen suppression (TAS) with Goserelin Acetate; Device: Radiation Therapy |
| Samarium-153 (2.0 mCi/kg) | Experimental | Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Receives: Drug: Samarium-153; Drug: Total Androgen Suppression (TAS) with Bicalutamide; Drug: Total androgen suppression (TAS) with Goserelin Acetate; Device: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Samarium-153
To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT).
Dose levels:
Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV
Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose.
Measured: 5 months (1 month HT, administration of drug, 4 months HT and RT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startMar 2003
- Primary completionFeb 2009
- Study completionJun 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Cytogen Corporation
- Responsible party
- Sponsor
- Investigators
- Edouard Trabulsi, MD, Principal investigator, Thomas Jefferson UniversityRichard Valicenti, MD, MA, Study chair, UC Davis School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328614
- Sponsor's protocol ID
- 02C.172
- Other IDs
- 2001-114, JT 1013
- Status last verified
- May 2025
- First submitted
- 19 May 2006
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00328614
- Acronym / sponsor ID
- 02C.172
- Conditions
- Prostate Cancer
- Keywords
- Locally advanced prostate cancer, positive lymph nodes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Cytogen Corporation
- Study start
- Mar 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Posted 8 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.
Detailed description
The likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. Bone-targeted therapy, when given sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metastatic prostate cancer patients.
The use of Samarium-153 EDTMP in conjunction with hormonal therapy and external beam radiation therapy has never been previously evaluated in high risk clinically localized prostate cancer. Many patients with high-risk prostate cancer develop progressive disease within 2 years of therapy indicating that subclinical metastatic disease may be present at the time of initial diagnosis. In these high-risk patients, there may be a therapeutic benefit of combining hormonal therapy with external beam radiation therapy and Samarium-153 EDTMP to treat localized and subclinical bony disease, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Samarium-153 (0.25 mCi/kg) | Experimental | Drug: Samarium-153, Drug: Total Androgen Suppression (TAS) with Bicalutamide, Drug: Total androgen suppression (TAS) with Goserelin Acetate, Device: Radiation TherapyCohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| Samarium-153 (0.5 mCi/kg) | Experimental | Drug: Samarium-153, Drug: Total Androgen Suppression (TAS) with Bicalutamide, Drug: Total androgen suppression (TAS) with Goserelin Acetate, Device: Radiation TherapyCohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| Samarium-153 (0.75 mCi/kg) | Experimental | Drug: Samarium-153, Drug: Total Androgen Suppression (TAS) with Bicalutamide, Drug: Total androgen suppression (TAS) with Goserelin Acetate, Device: Radiation TherapyCohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| Samarium-153 (1.0 mCi/kg) | Experimental | Drug: Samarium-153, Drug: Total Androgen Suppression (TAS) with Bicalutamide, Drug: Total androgen suppression (TAS) with Goserelin Acetate, Device: Radiation TherapyCohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| Samarium-153 (1.5 mCi/kg) | Experimental | Drug: Samarium-153, Drug: Total Androgen Suppression (TAS) with Bicalutamide, Drug: Total androgen suppression (TAS) with Goserelin Acetate, Device: Radiation TherapyCohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| Samarium-153 (2.0 mCi/kg) | Experimental | Drug: Samarium-153, Drug: Total Androgen Suppression (TAS) with Bicalutamide, Drug: Total androgen suppression (TAS) with Goserelin Acetate, Device: Radiation TherapyCohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PSA 20-150 and Gleason score greater than or equal to 7 or clinical stage greater than or equal to T2, Gleason greater than or equal to 8, PSA less than or equal to 150
- Pathologically positive lymph nodes
- Pretreatment must be prior to study entry and prior to any hormonal therapy
- Zubrod 0-1
- Adequate hematologic function
Key exclusion criteria (5 listed)
- Patients with PSA equal to or greater than 150
- Neuroendocrine features on histologic examination
- Radiologic evidence of metastatic disease
- Previous malignancy within last 5 years
- Prior pelvic radiation therapy or orchiectomy
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 |
|---|---|---|
| Samarium-153Also: Samarium-153-ethylene diamine tetramethylene phosphonate, Samarium (153Sm) lexidronam, QuadrametSamarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD). | Drug | Samarium-153 (0.25 mCi/kg), Samarium-153 (0.5 mCi/kg), Samarium-153 (0.75 mCi/kg), Samarium-153 (1.0 mCi/kg), Samarium-153 (1.5 mCi/kg), Samarium-153 (2.0 mCi/kg) |
| Total Androgen Suppression (TAS) with BicalutamideAlso: CasodexPatients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation. | Drug | Samarium-153 (0.25 mCi/kg), Samarium-153 (0.5 mCi/kg), Samarium-153 (0.75 mCi/kg), Samarium-153 (1.0 mCi/kg), Samarium-153 (1.5 mCi/kg), Samarium-153 (2.0 mCi/kg) |
| Total androgen suppression (TAS) with Goserelin AcetateAlso: ZoladexPatients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation. | Drug | Samarium-153 (0.25 mCi/kg), Samarium-153 (0.5 mCi/kg), Samarium-153 (0.75 mCi/kg), Samarium-153 (1.0 mCi/kg), Samarium-153 (1.5 mCi/kg), Samarium-153 (2.0 mCi/kg) |
| Radiation TherapyAlso: XRT, RadiotherapyRadiation therapy will begin 3 months following the initiation of hormone administration. Daily tumor doses will be given 5 days per week for 7-8 weeks. | Device | Samarium-153 (0.25 mCi/kg), Samarium-153 (0.5 mCi/kg), Samarium-153 (0.75 mCi/kg), Samarium-153 (1.0 mCi/kg), Samarium-153 (1.5 mCi/kg), Samarium-153 (2.0 mCi/kg) |
Primary outcome
Maximum Tolerated Dose of Samarium-153
Time frame: 5 months (1 month HT, administration of drug, 4 months HT and RT)
To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT). Dose levels: Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalsLink provided by the sponsor.
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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.
Edouard Trabulsi, MD principal investigator
Thomas Jefferson University
Richard Valicenti, MD, MA study chair
UC Davis School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Samarium-153, Total Androgen Suppression (TAS) with Bicalutamide and Total androgen suppression (TAS) with Goserelin Acetate in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site 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 5 inclusion and 5 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 8 Nov 2013). 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?
Maximum Tolerated Dose of Samarium-153 (time frame: 5 months (1 month HT, administration of drug, 4 months HT and RT)). 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 16 May 2025.