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Brief Title: PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases
Official Title: PEACE V: A Randomized Phase II Trial for the Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)
Study ID: NCT03569241
Brief Summary: A proportion of prostate cancer (PCa) patients develop relapse following curative local treatment. Regional nodal recurrence is an emerging clinical situation since the introduction of new molecular imaging methods in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of progression, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed. The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (salvage lymph node dissection, sLND or stereotactic body radiotherapy, SBRT) or MDT plus whole pelvis radiotherapy (WPRT: 45 Gy in 25 fractions).
Detailed Description: A proportion of prostate cancer (PCa) patients develop a local, regional (N1) or distant (M1) relapse following curative local treatment. For both local and distant relapses, different treatment recommendations are made in the guidelines (EAU guidelines 2016). However, the entity regional nodal recurrence is not mentioned in the guidelines but is an emerging clinical situation since the introduction of choline and more recently PSMA PET-CT in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of metastases, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed. The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (sLND or SBRT) or MDT plus WPRT. In the recurrent PCa setting, 2 recent trials have suggested a progression-free and even survival benefit of adding temporary ADT to local salvage prostate bed radiotherapy. Consequently, this positive effect might also be applicable for regional recurrences. Although the optimal duration of ADT is unknown, a minimal duration of 6 months of ADT seems advisable in this setting and will be mandatory for both arms. This trial will improve our insights in the pattern of recurrence following these treatment modalities with the expectation that WPRT will reduce the number of nodal relapses, improving metastasis-free survival and postponing the need for palliative systemic treatments while maintaining quality-of-life. The current phase II trial will try to establish a golden standard in the treatment of oligorecurrent nodal PCa.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Epworth Healthcare, Melbourne, , Australia
GZA, Antwerp, , Belgium
AZ St-Jan Brugge, Brugge, , Belgium
AZ St-Lucas, Brugge, , Belgium
Institut Jules Bordet, Brussel, , Belgium
AZ Maria Middelares, Gent, , Belgium
University Hospital Ghent, Ghent, , Belgium
AZ Groeninge, Kortrijk, , Belgium
UZ Leuven, Leuven, , Belgium
CH Mouscron, Mouscron, , Belgium
Humanitas Research Hospital, Milan, , Italy
Vita-Salute San Raffaele University, Milan, , Italy
Istituto Nazionale Tumori IRCCS, Napoli, , Italy
Fondazione IRCCS Policlinico S. Matteo, Pavia, , Italy
Ospedale Sacro Cuore-Don Calabria, Verona, , Italy
Oslo University Hospital, Oslo, , Norway
Cruces University Hospital, Barakaldo, , Spain
Clínica Universitaria IMQ, Bilbao, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Universitario Quironsalud, Madrid, , Spain
Hospitalario de Navarra, Navarro, , Spain
Hospital Clínico de Santiago, Santiago, , Spain
Hospital Universitari i Politècnic la Fe, Valencia, , Spain
Universitätsspital Basel, Basel, , Switzerland
Universitätsklinik für Radio-Onkologie, Bern, , Switzerland
Hôpitaux Universitaires de Genève, Geneva, , Switzerland
Kantonsspital St. Gallen, Saint Gallen, , Switzerland
UniversitätsSpital Zürich, Zürich, , Switzerland
Name: Piet Ost, PhD
Affiliation: University Hospital, Ghent
Role: PRINCIPAL_INVESTIGATOR