Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT]
Abstract Background Salvage radiotherapy (SRT) for prostate cancer (PCa) recurrence after prostatectomy offers long-term biochemical control in about 50–60% of patients. SRT is commonly initiated in patients with serum PSA levels < 1 ng/mL, a threshold at which standard-of-care imaging is insensi...
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| Format: | Article |
| Language: | English |
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BMC
2019-01-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-018-5200-1 |
| _version_ | 1811200849544740864 |
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| author | Jeremie Calais Johannes Czernin Wolfgang P. Fendler David Elashoff Nicholas G. Nickols |
| author_facet | Jeremie Calais Johannes Czernin Wolfgang P. Fendler David Elashoff Nicholas G. Nickols |
| author_sort | Jeremie Calais |
| collection | DOAJ |
| description | Abstract Background Salvage radiotherapy (SRT) for prostate cancer (PCa) recurrence after prostatectomy offers long-term biochemical control in about 50–60% of patients. SRT is commonly initiated in patients with serum PSA levels < 1 ng/mL, a threshold at which standard-of-care imaging is insensitive for detecting recurrence. As such, SRT target volumes are usually drawn in the absence of radiographically visible disease. 68Ga-PSMA-11 (PSMA) PET/CT molecular imaging is highly sensitive and may offer anatomic localization of PCa biochemical recurrence. However, it is unclear if incorporation of PSMA PET/CT imaging into the planning of SRT could improve its likelihood of success. The purpose of this trial is to evaluate the success rate of SRT for recurrence of PCa after prostatectomy with and without planning based on PSMA PET/CT. Methods We will randomize 193 patients to proceed with standard SRT (control arm 1, n = 90) or undergo a PSMA PET/CT scan (free of charge for patients) prior to SRT planning (investigational arm 2, n = 103). The primary endpoint is the success rate of SRT measured as biochemical progression-free survival (BPFS) after initiation of SRT. Biochemical progression is defined by PSA ≥ 0.2 ng/mL and rising. The randomization ratio of 1:1.13 is based on the assumption that approximately 13% of subjects randomized to Arm 2 will not be treated with SRT because of PSMA-positive extra-pelvic metastases. These patients will not be included in the primary endpoint analysis but will still be followed. The choice of treating the prostate bed alone vs prostate bed and pelvic lymph nodes, with or without androgen deprivation therapy (ADT), is selected by the treating radiation oncologist. The radiation oncologist may change the radiation plan depending on the findings of the PSMA PET/CT scan. Any other imaging is allowed for SRT planning in both arms if done per routine care. Patients will be followed until either one of the following conditions occur: 5 years after the date of initiation of randomization, biochemical progression, diagnosis of metastatic disease, initiation of any additional salvage therapy, death. Discussion This is the first randomized phase 3 prospective trial designed to determine whether PSMA PET/CT molecular imaging can improve outcomes in patients with PCa early BCR following radical prostatectomy. Acronym PSMA-SRT Phase 3 trial. Clinical trial registration ■ IND#130649◦ Submission: 04.26.2016◦ Safe-to-proceed letter issued by FDA: 05.25.2016 ■ UCLA IRB #18–000484,■ First submission: 3.27.2018■ Date of approval: 5.31.2018 ■ UCLA JCCC Short Title NUC MED 18–000484■ NCI Trial Identifier NCI-2018-01518■ ClinicalTrials.gov Identifier NCT03582774■ First Submitted: 06.19.2018■ First Submitted that Met QC Criteria: 06.27.2018■ First Posted: 07.11.2018■ Last Update Submitted that Met QC Criteria: 07.17.2018■ Last Update Posted: 07.19.2018 Trial status Current Trial Status Active as of 08/13/2018 Trial Start Date 09/01/2018-Actual Primary Completion Date 09/01/2023-Anticipated Trial Completion Date 09/01/2024-Anticipated |
| first_indexed | 2024-04-12T02:10:41Z |
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| id | doaj.art-e93e976c32eb48fab28000f54766cd09 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-12T02:10:41Z |
| publishDate | 2019-01-01 |
| publisher | BMC |
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| series | BMC Cancer |
| spelling | doaj.art-e93e976c32eb48fab28000f54766cd092022-12-22T03:52:24ZengBMCBMC Cancer1471-24072019-01-0119111110.1186/s12885-018-5200-1Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT]Jeremie Calais0Johannes Czernin1Wolfgang P. Fendler2David Elashoff3Nicholas G. Nickols4Department of Molecular & Medical Pharmacology, Ahmanson Translational Theranostics/ Imaging Division, University of CaliforniaDepartment of Molecular & Medical Pharmacology, Ahmanson Translational Theranostics/ Imaging Division, University of CaliforniaDepartment of Molecular & Medical Pharmacology, Ahmanson Translational Theranostics/ Imaging Division, University of CaliforniaDepartment of Medicine Statistics Core (DOMStat), UCLA CTSI Biostatistics and Computational Biology, University of CaliforniaDepartment of Radiation Oncology, University of CaliforniaAbstract Background Salvage radiotherapy (SRT) for prostate cancer (PCa) recurrence after prostatectomy offers long-term biochemical control in about 50–60% of patients. SRT is commonly initiated in patients with serum PSA levels < 1 ng/mL, a threshold at which standard-of-care imaging is insensitive for detecting recurrence. As such, SRT target volumes are usually drawn in the absence of radiographically visible disease. 68Ga-PSMA-11 (PSMA) PET/CT molecular imaging is highly sensitive and may offer anatomic localization of PCa biochemical recurrence. However, it is unclear if incorporation of PSMA PET/CT imaging into the planning of SRT could improve its likelihood of success. The purpose of this trial is to evaluate the success rate of SRT for recurrence of PCa after prostatectomy with and without planning based on PSMA PET/CT. Methods We will randomize 193 patients to proceed with standard SRT (control arm 1, n = 90) or undergo a PSMA PET/CT scan (free of charge for patients) prior to SRT planning (investigational arm 2, n = 103). The primary endpoint is the success rate of SRT measured as biochemical progression-free survival (BPFS) after initiation of SRT. Biochemical progression is defined by PSA ≥ 0.2 ng/mL and rising. The randomization ratio of 1:1.13 is based on the assumption that approximately 13% of subjects randomized to Arm 2 will not be treated with SRT because of PSMA-positive extra-pelvic metastases. These patients will not be included in the primary endpoint analysis but will still be followed. The choice of treating the prostate bed alone vs prostate bed and pelvic lymph nodes, with or without androgen deprivation therapy (ADT), is selected by the treating radiation oncologist. The radiation oncologist may change the radiation plan depending on the findings of the PSMA PET/CT scan. Any other imaging is allowed for SRT planning in both arms if done per routine care. Patients will be followed until either one of the following conditions occur: 5 years after the date of initiation of randomization, biochemical progression, diagnosis of metastatic disease, initiation of any additional salvage therapy, death. Discussion This is the first randomized phase 3 prospective trial designed to determine whether PSMA PET/CT molecular imaging can improve outcomes in patients with PCa early BCR following radical prostatectomy. Acronym PSMA-SRT Phase 3 trial. Clinical trial registration ■ IND#130649◦ Submission: 04.26.2016◦ Safe-to-proceed letter issued by FDA: 05.25.2016 ■ UCLA IRB #18–000484,■ First submission: 3.27.2018■ Date of approval: 5.31.2018 ■ UCLA JCCC Short Title NUC MED 18–000484■ NCI Trial Identifier NCI-2018-01518■ ClinicalTrials.gov Identifier NCT03582774■ First Submitted: 06.19.2018■ First Submitted that Met QC Criteria: 06.27.2018■ First Posted: 07.11.2018■ Last Update Submitted that Met QC Criteria: 07.17.2018■ Last Update Posted: 07.19.2018 Trial status Current Trial Status Active as of 08/13/2018 Trial Start Date 09/01/2018-Actual Primary Completion Date 09/01/2023-Anticipated Trial Completion Date 09/01/2024-Anticipatedhttp://link.springer.com/article/10.1186/s12885-018-5200-1Prostate cancerPSMAPET/CTRandomized phase 3 trialSalvage radiation therapy |
| spellingShingle | Jeremie Calais Johannes Czernin Wolfgang P. Fendler David Elashoff Nicholas G. Nickols Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT] BMC Cancer Prostate cancer PSMA PET/CT Randomized phase 3 trial Salvage radiation therapy |
| title | Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT] |
| title_full | Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT] |
| title_fullStr | Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT] |
| title_full_unstemmed | Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT] |
| title_short | Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT] |
| title_sort | randomized prospective phase iii trial of 68ga psma 11 pet ct molecular imaging for prostate cancer salvage radiotherapy planning psma srt |
| topic | Prostate cancer PSMA PET/CT Randomized phase 3 trial Salvage radiation therapy |
| url | http://link.springer.com/article/10.1186/s12885-018-5200-1 |
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