A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy – The PROPER 1 trial
Background and purpose: The treatment of biochemical recurrence (BCR) after prostatectomy is challenging as the site of the recurrence is often undetectable. Our aim was to test a personalised treatment concept for BCR based on PSA kinetics during salvage radiotherapy (SRT) combined with prostate-sp...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-09-01
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| Series: | Clinical and Translational Radiation Oncology |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405630822000544 |
| _version_ | 1811281333630009344 |
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| author | Adalsteinn Gunnlaugsson Vilberg Johannesson Elinore Wieslander Eva Brun Ulrika Bitzén Olof Ståhl Ola Bratt Göran Ahlgren Tomas Ohlsson Elisabeth Kjellén Per Nilsson |
| author_facet | Adalsteinn Gunnlaugsson Vilberg Johannesson Elinore Wieslander Eva Brun Ulrika Bitzén Olof Ståhl Ola Bratt Göran Ahlgren Tomas Ohlsson Elisabeth Kjellén Per Nilsson |
| author_sort | Adalsteinn Gunnlaugsson |
| collection | DOAJ |
| description | Background and purpose: The treatment of biochemical recurrence (BCR) after prostatectomy is challenging as the site of the recurrence is often undetectable. Our aim was to test a personalised treatment concept for BCR based on PSA kinetics during salvage radiotherapy (SRT) combined with prostate-specific membrane antigen positron emission tomography (PSMA-PET). Materials and methods: This phase II trial included 100 patients with BCR. PSMA-PET was performed at baseline. PSA was measured weekly during SRT. Initially, 70 Gy in 35 fractions was prescribed to the prostate bed. Radiotherapy was adapted after 50 Gy. Non-responders (PSA still ≥ 0.15 ng/mL) received sequential lymph node irradiation with a boost to PSMA-PET positive lesions, while responders (PSA < 0.15 ng/mL) continued SRT as planned. PET-findings were only taken into consideration for treatment planning in case of PSA non-response after 50 Gy. Results: Data from 97 patients were eligible for analysis. Thirty-four patients were classified as responders and 63 as non-responders. PSMA-PET was positive in 3 patients (9%) in the responder group and in 22 (35%) in the non-responder group (p = 0.007). The three-year failure-free survival was 94% for responders and 68% for non-responders (median follow-up 38 months). There were no significant differences in physician-reported urinary and bowel toxicity. Patient-reported diarrhoea at end of SRT was more common among non-responders. Conclusion: This new personalised treatment concept with intensified SRT based on PSA response demonstrated a high tumour control rate in both responders and non-responders. These results suggest a clinically significant effect with moderate side effects in a patient group with otherwise poor prognosis. PSMA-PET added limited value. The treatment approach is now being evaluated in a phase III trial.Clinical trial registration numbers: NCT02699424&ISRCTN45905321. |
| first_indexed | 2024-04-13T01:31:47Z |
| format | Article |
| id | doaj.art-2e80e2d99b4a40bb8a27ed43eb167633 |
| institution | Directory Open Access Journal |
| issn | 2405-6308 |
| language | English |
| last_indexed | 2024-04-13T01:31:47Z |
| publishDate | 2022-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Clinical and Translational Radiation Oncology |
| spelling | doaj.art-2e80e2d99b4a40bb8a27ed43eb1676332022-12-22T03:08:30ZengElsevierClinical and Translational Radiation Oncology2405-63082022-09-01367782A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy – The PROPER 1 trialAdalsteinn Gunnlaugsson0Vilberg Johannesson1Elinore Wieslander2Eva Brun3Ulrika Bitzén4Olof Ståhl5Ola Bratt6Göran Ahlgren7Tomas Ohlsson8Elisabeth Kjellén9Per Nilsson10Department of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Lund, Sweden; Corresponding author at: Department of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Klinikgatan 5, 22185 Lund, Sweden.Department of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Lund, SwedenDepartment of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Lund, SwedenDepartment of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Lund, SwedenDepartment of Clinical Physiology and Nuclear Medicine, Skåne University Hospital and Lund University, Lund, SwedenDepartment of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Lund, SwedenDepartment of Urology, Sahlgrenska University Hospital and Institute of Clinical Science Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenThe Peritus Clinic, Lund, SwedenDepartment of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Lund, SwedenDepartment of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Lund, SwedenDepartment of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Lund, SwedenBackground and purpose: The treatment of biochemical recurrence (BCR) after prostatectomy is challenging as the site of the recurrence is often undetectable. Our aim was to test a personalised treatment concept for BCR based on PSA kinetics during salvage radiotherapy (SRT) combined with prostate-specific membrane antigen positron emission tomography (PSMA-PET). Materials and methods: This phase II trial included 100 patients with BCR. PSMA-PET was performed at baseline. PSA was measured weekly during SRT. Initially, 70 Gy in 35 fractions was prescribed to the prostate bed. Radiotherapy was adapted after 50 Gy. Non-responders (PSA still ≥ 0.15 ng/mL) received sequential lymph node irradiation with a boost to PSMA-PET positive lesions, while responders (PSA < 0.15 ng/mL) continued SRT as planned. PET-findings were only taken into consideration for treatment planning in case of PSA non-response after 50 Gy. Results: Data from 97 patients were eligible for analysis. Thirty-four patients were classified as responders and 63 as non-responders. PSMA-PET was positive in 3 patients (9%) in the responder group and in 22 (35%) in the non-responder group (p = 0.007). The three-year failure-free survival was 94% for responders and 68% for non-responders (median follow-up 38 months). There were no significant differences in physician-reported urinary and bowel toxicity. Patient-reported diarrhoea at end of SRT was more common among non-responders. Conclusion: This new personalised treatment concept with intensified SRT based on PSA response demonstrated a high tumour control rate in both responders and non-responders. These results suggest a clinically significant effect with moderate side effects in a patient group with otherwise poor prognosis. PSMA-PET added limited value. The treatment approach is now being evaluated in a phase III trial.Clinical trial registration numbers: NCT02699424&ISRCTN45905321.http://www.sciencedirect.com/science/article/pii/S2405630822000544Salvage radiotherapyProstate cancerAdaptiveProstate specific antigenProstate specific membrane antigen |
| spellingShingle | Adalsteinn Gunnlaugsson Vilberg Johannesson Elinore Wieslander Eva Brun Ulrika Bitzén Olof Ståhl Ola Bratt Göran Ahlgren Tomas Ohlsson Elisabeth Kjellén Per Nilsson A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy – The PROPER 1 trial Clinical and Translational Radiation Oncology Salvage radiotherapy Prostate cancer Adaptive Prostate specific antigen Prostate specific membrane antigen |
| title | A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy – The PROPER 1 trial |
| title_full | A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy – The PROPER 1 trial |
| title_fullStr | A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy – The PROPER 1 trial |
| title_full_unstemmed | A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy – The PROPER 1 trial |
| title_short | A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy – The PROPER 1 trial |
| title_sort | prospective phase ii study of prostate specific antigen guided salvage radiotherapy and 68ga psma pet for biochemical relapse after radical prostatectomy the proper 1 trial |
| topic | Salvage radiotherapy Prostate cancer Adaptive Prostate specific antigen Prostate specific membrane antigen |
| url | http://www.sciencedirect.com/science/article/pii/S2405630822000544 |
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