Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy (LuTectomy)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04430192 |
|
Recruitment Status :
Active, not recruiting
First Posted : June 12, 2020
Last Update Posted : May 10, 2022
|
Sponsor:
Peter MacCallum Cancer Centre, Australia
Collaborators:
Movember Foundation
Medical Research Future Fund
Endocyte
E.J. Whitten Foundation Prostate Cancer Research Centre
Information provided by (Responsible Party):
Peter MacCallum Cancer Centre, Australia
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 21, 2020 | |||||||||
| First Posted Date ICMJE | June 12, 2020 | |||||||||
| Last Update Posted Date | May 10, 2022 | |||||||||
| Actual Study Start Date ICMJE | August 6, 2020 | |||||||||
| Estimated Primary Completion Date | August 7, 2022 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
To determine the radiation absorbed dose in the prostate and involved lymph nodes following one or two administrations of Lu-PSMA in men with HRCaP prior to radical prostatectomy [ Time Frame: Determined using imaging at 4, 24 and 96 hrs after administration of Lu-PSMA ] Establishing the absorbed radiation dose in the prostate and involved lymph nodes (Gy)
|
|||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
|
|||||||||
| Original Secondary Outcome Measures ICMJE |
|
|||||||||
| Current Other Pre-specified Outcome Measures |
|
|||||||||
| Original Other Pre-specified Outcome Measures | Same as current | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy | |||||||||
| Official Title ICMJE | Study of the Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Radionuclide Therapy Prior to Radical Prostatectomy in Men With High-risk Localised Prostate Cancer | |||||||||
| Brief Summary | This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND) | |||||||||
| Detailed Description | This open label, phase I/II non-randomised clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Patients will receive one or two cycles of 177Lu-PSMA followed by surgery. The primary objective is to determine the radiation absorbed dose in the prostate and involved lymph nodes. Secondary objectives include evaluating imaging response to therapy using PSMA-PET, biochemical response, pathological response, adverse effects of Lu-PSMA and surgical safety, and health-related Quality of Life (QoL). | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
|||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||||||||
| Condition ICMJE | Prostatic Neoplasms | |||||||||
| Intervention ICMJE | Drug: 177Lu-PSMA-617
Patients 1-10 will be given 5GBq of 177Lu-PSMA. Patients 11-20 will be given 2 cycles of 5GBq of 177Lu-PSMA, separated by 6 weeks.
Other Names:
|
|||||||||
| Study Arms ICMJE | Experimental: 177Lu-PSMA-617 followed by prostatectomy
177Lu-PSMA-617 followed by prostatectomy
Intervention: Drug: 177Lu-PSMA-617
|
|||||||||
| Publications * | Not Provided | |||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Estimated Enrollment ICMJE |
20 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | June 30, 2023 | |||||||||
| Estimated Primary Completion Date | August 7, 2022 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
| Sex/Gender ICMJE |
|
|||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Australia | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT04430192 | |||||||||
| Other Study ID Numbers ICMJE | 19_245 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
|
|||||||||
| IPD Sharing Statement ICMJE |
|
|||||||||
| Current Responsible Party | Peter MacCallum Cancer Centre, Australia | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Peter MacCallum Cancer Centre, Australia | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE |
|
|||||||||
| Investigators ICMJE |
|
|||||||||
| PRS Account | Peter MacCallum Cancer Centre, Australia | |||||||||
| Verification Date | May 2022 | |||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||||||||