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


Condition: Prostate Cancer, Prostate Cancer Metastatic, Metastatic Cancer, Oligometastatic Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03569241

Sponsor: University Ghent

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically proven initial diagnosis of adenocarcinoma of the prostate
  • Biochemical relapse of prostate cancer following radical local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant/ salvage radiotherapy) according to the EAU guidelines 2016.
  • Following radical prostatectomy, patients with a biochemical relapse are eligible in case a nodal relapse is detected in the pelvis even in the absence of prior postoperative prostate bed radiotherapy (adjuvant or salvage).
  • In case of a suspected local recurrence following primary radiotherapy, a biopsy should confirm local recurrence and patients with a confirmed local recurrence are eligible in case they also undergo a local salvage therapy. If imaging rules out local relapse, patients are eligible.
  • Nodal relapse in the pelvis on choline, PSMA or FACBC PET-CT with a maximum of 3 positive nodal lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation.
  • WHO performance state 0-1
  • Age >18 years
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

  • Bone or visceral metastases
  • Para-aortic lymph node metastases (above the aortic bifurcation)
  • Local relapse in the prostate gland or prostate bed not suitable for a curative treatment
  • Previous irradiation of the pelvic and or para-aortic nodes
  • Serum testosterone level <50ng/dl or 1.7 nmol/L at time of randomization
  • Symptomatic metastases
  • Lymph node metastases in previously irradiated areas resulting in dose constraint violation
  • Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease)
  • Contraindications to androgen deprivation therapy
  • PSA rise while on active treatment with (LHRH-agonist, LHRH-antagonist, anti-androgen, estrogen
  • Previous treatment with cytotoxic agent for PCa
  • Treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
  • Other active malignancy, except non-melanoma skin cancer or other malignancies with a documented disease-free survival for a minimum of 3 years before randomization.

View trial on ClinicalTrials.gov


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