Metastasis-directed Therapy in Castration-refractory Prostate Cancer

NCT04222634 | Active Not Recruiting

• 1 other identifier: S63177
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to define the postponement of next line systemic treatment (NEST), by the use of metastasis-directed therapy in patients with oligoprogressive castration-refractory prostate cancer. This will be defined by the NEST-free survival. Furthermore the investigators will use 18F PSMA PET-CT as investigational imaging, to assess the predictive value and impact on treatment policy.

Conditions

Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Next-line Systemic Treatment - free survival (NEST-FS)

  Time until the start with a subsequent systemic treatment line calculated from the last day of MDT until the first day of NEST or death (whichever comes first)

  up to 5 years after MDT

• PSMA PET-CT accuracy and predictive value

  We will evaluate if (1) at time of PSA progression, new lesions will be visible on PSMA PET-CT and not on conventional imaging or visible on both, (2) if those new lesions at time of radiographic progression were already visible as active lesions on PSMA PET-CT (and not on conventional imaging) at time of inclusion, and (3) we will evaluate if active lesions visible at PSMA PET-CT at initial diagnosis of oligoprogression/at time of inclusion, who are not visible on conventional imaging might disappear without targetet treatment. We will evaluate if PSMA PET-CT would result in a change of patient management.

  up to 5 years after MDT

Secondary Outcomes (7)

• PSA response

  up to 5 years after MDT

• Clinical progression-free survival (cPFS)

  up to 5 years after MDT

• Cancer-specific survival (CSS)

  up to 10 years after MDT

• Overall survival (OS)

  up to 10 years after MDT

• Acute and late toxicity (in case of radiotherapy)

  up to 5 years after MDT

Study Arms (1)

MDT for oligoprogressive lesions in CRPC

OTHER

metastasis-directed therapy: * radiotherapy (SBRT or conventional radiotherapy in case of local recurrence or untreated primary tumor) * metastasectomy * salvage lymphadenectomy * salvage prostatectomy in case of local recurrence or untreated primary tumor

Other: Radiotherapy (SBRT) and/or surgery (metastasectomy)

Interventions

Radiotherapy (SBRT) and/or surgery (metastasectomy) OTHER

Metastasis-directed therapy (surgery and/or radiotherapy) as treatment for oligoprogressive lesions

MDT for oligoprogressive lesions in CRPC

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male -\> prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven initial diagnosis of adenocarcinoma of the prostate
• mCRPC setting, with testosterone level \< 50 ng/dl or 1.7 nmol/l
• Oligoprogressive disease, defined as a maximum of 3 extracranial metastases in any organ system OR local recurrence, diagnosed on conventional imaging with CT and bone scan. This may present as either the progression of pre-existing disease, and/or the appearance of new metastases. (defined according to the PCWG 3 criteria (20), see section 6. Trial Procedures)
• Patients currently treated with ADT, whether or not combined with another systemic treatment such as abiraterone acetate, enzalutamide, docetaxel and radium-223. Denosumab is allowed but not considered as second-line systemic treatment.
• Priory treated primary tumor by radiotherapy or surgery. If the primary tumour is not treated, local therapy should be added to the treatment. Both radiotherapy as well as surgery are allowed.
• WHO performance status 0-1
• Age \>= 18 years old
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and/or follow-up schedule. Those conditions should be discussed with the patient before registration in the trial.
• Patient presented at the multidisciplinary tumour board of the local hospital.
• Before patient registration/randomization, written informed consent must be given according to ICH/GCO and national/local regulations.

You may not qualify if:

• Serum testosterone level \> 50 ng/ml or \> 1.7 nmol/l.
• Presence of polyprogression, defined as more than 3 progressive/new metastatic lesions and/or local recurrence (which counts for 1 lesion).
• Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial.
• Previous treatments (RT, surgery) or comorbidities rendering PDT impossible.
• Disorder precluding understanding of trial information or informed consent or signing informed consent.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Gert De Meerleer

Leuven, 3000, Belgium

Location

Related Publications (1)

• Berghen C, Joniau S, Rans K, Devos G, Poels K, Slabbaert K, Dumez H, Albersen M, Goffin K, Haustermans K, De Meerleer G. Metastasis-directed therapy in castration-refractory prostate cancer (MEDCARE): a non-randomized phase 2 trial. BMC Cancer. 2020 May 24;20(1):457. doi: 10.1186/s12885-020-06853-x.

  PMID: 32448171 DERIVED

MeSH Terms

Interventions

Radiotherapy; Radiosurgery; Metastasectomy

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gert De Meerleer, Ph.D., M.D.

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single arm study

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 10, 2020
• Study Start: December 27, 2019
• Primary Completion: July 25, 2023
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)