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Genital Diseases, Male

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Metastasis-directed therapy (salvage lymph node dissection OR stereotactic body radiotherapy) + 6 months androgen deprivation therapy

Metastasis-directed therapy (salvage lymph node dissection OR stereotactic body radiotherapy) + whole pelvic radiotherapy + 6 months androgen deprivation therapy

addition of prophylactic whole pelvic radiotherapy to a local metastasis-directed treatment

whole pelvic radiotherapy

metastasis-directed treatment

salvage Lymph Node Dissection

LHRH-agonist (+ anti-androgen) or antagonist for a duration of 6 months

androgen deprivation therapy

Piet Ost, PhD

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).

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.

PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases

PEACE V: A Randomized Phase II Trial for the Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)

Metastasis-free survival will be defined as the time between randomization and the appearance of a metastatic recurrence (any M1) as suggested by choline, FACBC or PSMA PET-CT or death due to any cause

Clinical Progression-free survival is defined as time between randomization and the appearance of a new recurrence (any N1 or M1) as suggested by PET-CT, symptoms related to progressive PCa, or death due to any cause

For patients who had previous RP at initial diagnosis, a biochemical recurrence is defined by any confirmed PSA rise above 0.20 ng/ml with a confirmatory rise at least 2 weeks later. For patients who had previous RT to the prostate at initial diagnosis, a biochemical recurrence is defined as the nadir + 2ng/ml (Phoenix definition). Non-responders are considered to have a biochemical recurrence in case a second measurement at least 2 weeks later confirms a rising PSA

Radiotherapy toxicity will be assessed according to NCI CTCAE v4.0.

Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients

Validated questionnaire assessing the health-related QOL of prostate cancer patients

Cancer specific survival will be read as the time from trial randomization to the date of death due to prostate cancer

Overall survival will be read as the time from trial randomization to the date of death from any cause

Time to hormonal treatment is defined as the time from trial randomization to start of hormonal treatment

Time to castration resistant disease is defined as the time from trial randomization until castration resistant status

Assessment of quality-adjusted-life-years with the EuroQol classification system (EQ-5D-5L)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases	NCT03569241	Prostate Cancer Prostate Cancer... Metastatic Canc... Oligometastatic...	whole pelvic ra... metastasis-dire... salvage Lymph N... androgen depriv...	18 Years -	University Hospital, Ghent
PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases	NCT03569241	Prostate Cancer Prostate Cancer... Metastatic Canc... Oligometastatic...	whole pelvic ra... metastasis-dire... salvage Lymph N... androgen depriv...	18 Years -	University Hospital, Ghent

Spots Global Cancer Trial Database for whole pelvic radiotherapy