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| Name | Class |
|---|---|
| Varian, a Siemens Healthineers Company | INDUSTRY |
| Telix Pharmaceuticals (Innovations) Pty Ltd | INDUSTRY |
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The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.
This study will enroll patients with poly-metastatic hormone-sensitive prostate cancer, as identified by baseline PSMA PET imaging. All participants will undergo standard of care systemic therapy, including ADT and androgen receptor signaling inhibitors intensification as clinically indicated, for up to three months before protocol radiotherapy. The treating radiation oncologist will pre-plan SABR to a total of 35-40 Gy in 5 fractions. The study will consist of initially delivering three qWeekly SABR "pulses" to all identified metastatic sites. The initial pulse should start within 60 (+/-30 days) of initiation of ADT. Following the third pulse, interim PSMA PET imaging will be repeated at 6 months from initiation of ADT (-30 days allowed) to evaluate the response on a per lesion basis (See Section 6.1.2.1). In the absence of a complete response (CR) for a given lesion, two additional qWeekly pulses may be delivered to these sites within 60 days from interim PSMA PET. PSMA avid lesions identified at baseline will be monitored on interim and follow up scan, and new PSMA avid lesions will require confirmation through conventional imaging. If patients exhibit progression on PSA or conventional imaging, they will exit the trial and undergo systemic therapy intensification. More detailed specifications on systemic therapy and SABR and their parameters are provided in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SINGLE ARM UNBLINDED SINGLE SITE PILOT | Experimental | Study will enroll patients with poly-metastatic hormone-sensitive prostate cancer, as identified by baseline PSMA PET imaging.Patients will undergo standard of care systemic therapy,including ADT & androgen receptor signaling inhibitors intensification as clinically indicated,for up to 3 months before protocol radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: 68-Ga PSMA11 | Drug | 0-3 months since initiation of ADT. Baseline PSMA PET imaging. 4-20 sites of metastasis by PSMA PET Will be injected/assessed in line with its FDA label. Other Name: |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in PSMA-positive TTV | will be measured by the decrease in TTV (%) on a per-patient basis between the initial scan and post-SABR PSMA PET. | 1 YEAR |
| Reduction in SABR treatment intensity | Will be measured by the decrease in proportion of tumor lesions treated to initially prescribed 5 fractions (%) due specifically to complete metabolic response on interim PET PSMA after 3 fractions, as compared to initially planned lesions on a per patient basis. | 1 YEAR |
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Inclusion Criteria:
Exclusion Criteria:
This study is enrolling men with 4-20 sites of metastasis from prostate cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SARAH NEUFELD, MS, MBA | Contact | 214 645 8525 | sarah.hardee@UTSouthwestern.edu | |
| DANIEL YANG, MD | Contact | 214 645 8525 | daniel.yang@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| DANIEL YANG, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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1 site pilot study with intent to characterize dynamic range of response by PET PSMA-11 68Ga characterization of poly-metastatic prostate cancer lesions & safe delivery of comprehensive SABR using adaption based on PSMA metabolic response.Patients will undergo standard of care therapy, including ADT & androgen receptor signaling inhibitors intensification as clinically indicated,for up to 3 months before protocol radiotherapy.The radiation oncologist will pre-plan SABR to a total of 35-40 Gy in 5 fractions. Trial will consist of initially delivering 3 qWeekly SABR "pulses" to all identified metastatic sites.First pulse should start within 60 (+/-30 days)of start of ADT. Following pulse 3,interim PSMA PET imaging to be repeated at 6 months from initiation of ADT(-30 days allowed)to evaluate response on a per lesion basis.In the absence of a complete response (CR) for a given lesion,2 additional qWeekly pulses may be delivered to these sites within 60 days from interim PSMA PET.
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| Adaptive stereotactic ablative radiotherapy (SABR) | Radiation | Pre-plan 5 fraction SABR 35-40 Gy. SOC systemic therapy allows for ADT and ARSI intensification. Delivery of 3 pulses to all sites. Pulses delivered weekly. |
|
| 68Ga-PSMA-11 | Drug | Repeat PSMA PET imaging at 6 months post-ADT initiation. Radiation of primary allows. Will be injected/assessed in line with its FDA label. |
|
| Adaptive stereotactive ablative radiotherapy (SABR) | Radiation | Delivery of 2 additional pulses to all remaining PSMA PET visible sites |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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