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
- Age: minimum 18 Years maximum N/A
- Gender: Male
- 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.
- 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