PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases

• Register: ClinicalTrials.gov
• Last refreshed on: 10 July 2023
• Main ID: NCT03569241
• Date of registration: 14/06/2018
• Prospective Registration: No
• Primary sponsor: University Ghent
• Public title: PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases STORM
• Scientific title: PEACE V: A Randomized Phase II Trial for the Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)
• Date of first enrolment: April 27, 2018
• Target sample size: 196
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03569241
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Germany, Italy, Netherlands, Norway, Spain, Switzerland

Contacts

• Name: Piet Ost, PhD
• Affiliation: University Hospital, Ghent

Key inclusion & exclusion criteria

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.



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

Health Condition(s) or Problem(s) studied

Oligometastatic Cancer

Prostate Cancer

Metastatic Cancer

Prostate Cancer Metastatic

Intervention(s)

Radiation: metastasis-directed treatment

Procedure: salvage Lymph Node Dissection

Drug: androgen deprivation therapy

Radiation: whole pelvic radiotherapy

Primary Outcome(s)

Metastases-free survival [Time Frame: 2 year]

Secondary Outcome(s)

economical evaluation [Time Frame: 2 year]

Toxicity: late toxicity [Time Frame: 2 year]

Overall survival [Time Frame: 5 year]

Patient reported QOL as per EORTC-QLQ PR25 [Time Frame: 2 year]

Time to castration-resistant disease [Time Frame: 5 year]

Toxicity: acute toxicity [Time Frame: 3 months]

Prostate cancer-specific survival [Time Frame: 5 year]

Sensitivity/specificity of PET-CT for the detection of nodal recurrences: limited to patients undergoing surgery [Time Frame: 3 months]

Clinical Progression free survival [Time Frame: 2 year]

Patient reported QOL as per EORTC-QLQ C30 [Time Frame: 2 year]

Time to start of hormonal treatment [Time Frame: 2 year]

Biochemical progression-free survival [Time Frame: 2 year]

Secondary ID(s)

EC/2018/0130

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Geneva