Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer

NCT06585007 | Recruiting Phase 3

• 2 other identifiers: S671302022-502254-13-00
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.

Conditions

Castration-resistant Prostate Cancer; Oligoprogressive

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall Survival

  will be calculated from the day of randomisation until death from any cause, wichever came first, assessed up to 5 years.

Secondary Outcomes (6)

• Quality of life scoring EORTC QLQ-C30

  Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24

• Quality of life scoring EORTC QLQ-PR25

  Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24

• Quality of life scoring EQ-5D-5L

  Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24

• Cancer Specific Survival

  will be calculated from the day of randomisation until prostate cancer death, assessed up to 5 years.

• Radiographic progression free survival

  will be calculated from the day of randomisation until the first day of progression (local, nodal or metastatic). Imaging is performed every 6 months during follow-up or at any time in case of PSA progression or symptoms, assessed up to 5 years.

Study Arms (2)

Standard of care therapy

NO INTERVENTION

The standard of care can consist of surveillance (which means the continuation of the ongoing systemic treatment without any change) or initiation of NEST. The decision which option is considered must be decided at the multidisciplinary urologic oncology meeting (obligatory). MDT is not allowed in this arm. Options for NEST in this trial are abiraterone acetate, enzalutamide, apalutamide, darolutamide, olaparib, talazoparib, niraparib, cabazitaxel and docetaxel, radium-223, luthetium-177-PSMA.

Progression-directed therapy

EXPERIMENTAL

PDT (metastasectomy or SBRT) while continuing current systemic therapy: androgen-deprivation (ADT) alone, or ADT in combination with abiraterone acetate, enzalutamide, apalutamide and patients who had received docetaxel in the past. Patients under current treatment with docetaxel are not allowed, because the hypothesized interaction between docetaxel and radiotherapy concerning toxicity. In case of oligoprogression after PDT, repeated PDT to the new lesions is mandatory.

Radiation: Radiotherapy; Procedure: metastasectomy

Interventions

Radiotherapy RADIATION

Progression-directed therapy (stereotactic body radiation therapy)

Progression-directed therapy

metastasectomy PROCEDURE

Progression-directed therapy (metastasectomy)

Progression-directed therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• Acinar adenocarcinoma (inclusive neuro-endocrine dedifferentiation).
• Oligoprogressive disease on conventional imagine within a maximum of 6 weeks prior to randomisation defined as: a maximum of 3 extracranial progressive lesions (pre-existing lesions, the development of new lesions, or both) in any organ. Nodal (N1) disease should be measured in the short axis. Nodes more than 1.5 cm in the short axis are considered pathologic and measurable. Oligoprogression on bone scan is defined as the occurrence of maximal 3 new and/or progressive lesions. In case of not unambiguously, additional imaging such as diagnostic magnetic resonance imaging (MRI) or dedicated CT-scan should be performed. Visceral disease reported separately (lung, liver, adrenal, or CNS) and is considered measurable if an individual lesions is more than 1 cm longest dimension.
• Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1).
• Patients with oligoprogressive disease with pADT +/- second line systemic therapy. This is both the combination of pADT + ARTA as ongoing treatment or patients who had received docetaxel in the past (Type 2).
• Castration-refractory disease, defined as testosterone level \< 50 ng/dL.
• Prior treatment of the primary tumor by radiotherapy or surgery. If the primary tumor has not been treated previously, this treatment is obligatory within the trial.
• WHO performance 0-2
• Age \>= 18 years old
• Absence of psychological, sociological, or geographical condition potentially hampering compliance with study protocol.

You may not qualify if:

• Ductal adenocarcinoma and small-cell prostate cancer.
• Serum testosterone level \> 50 ng/ml.
• Presence of poly-progressive disease, defined as more than 3 progressive lesions on conventional imaging or nodal and/or metastatic lesions on conventional imaging
• Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial.
• Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible.
• Spinal bone lesion that is highly symptomatic, neurologically threatening or at risk of fracture.
• Patients already treated with radionuclides, cabazitaxel or PARP-inhibitors in the past.
• Patients with progressive disease while receiving docetaxel.
• Not able to understand the treatment protocol or sign informed consent.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

RECRUITING

MeSH Terms

Interventions

Radiotherapy; Metastasectomy

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Gert De Meerleer, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kato Rans, MD

CONTACT

003216347600; kato.rans@uzleuven.be

Gert De Meerleer, MD, PhD

CONTACT

003216347600; gert.demeerleer@uzleuven.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: September 5, 2024
• Study Start: December 19, 2023
• Primary Completion (Estimated): January 20, 2029
• Study Completion (Estimated): January 20, 2029
• Last Updated: September 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)