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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

Gunnlaugsson, Adalsteinn LU ; Johannesson, Vilberg LU ; Wieslander, Elinore LU ; Brun, Eva LU ; Bitzen, Ulrika LU ; Ståhl, Olof LU ; Bratt, Ola LU ; Ahlgren, Göran LU ; Ohlsson, Tomas and Kjellén, Elisabeth LU , et al. (2022) In Clinical and Translational Radiation Oncology 36. p.77-82
Abstract

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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Clinical and Translational Radiation Oncology
volume
36
pages
77 - 82
publisher
Elsevier
external identifiers
  • pmid:35873652
  • scopus:85134818869
ISSN
2405-6308
DOI
10.1016/j.ctro.2022.07.001
language
English
LU publication?
yes
additional info
© 2022 The Authors.
id
6d34a2aa-4eab-4f2e-9d78-533e8b37e302
date added to LUP
2022-08-11 08:16:23
date last changed
2024-09-19 21:20:36
@article{6d34a2aa-4eab-4f2e-9d78-533e8b37e302,
  abstract     = {{<p>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).</p><p>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 &lt; 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.</p><p>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.</p><p>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&amp;ISRCTN45905321.</p>}},
  author       = {{Gunnlaugsson, Adalsteinn and Johannesson, Vilberg and Wieslander, Elinore and Brun, Eva and Bitzen, Ulrika and Ståhl, Olof and Bratt, Ola and Ahlgren, Göran and Ohlsson, Tomas and Kjellén, Elisabeth and Nilsson, Per}},
  issn         = {{2405-6308}},
  language     = {{eng}},
  pages        = {{77--82}},
  publisher    = {{Elsevier}},
  series       = {{Clinical and Translational Radiation Oncology}},
  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}},
  url          = {{http://dx.doi.org/10.1016/j.ctro.2022.07.001}},
  doi          = {{10.1016/j.ctro.2022.07.001}},
  volume       = {{36}},
  year         = {{2022}},
}