68Ga-PSMA-PET/CT and Genomic Alterations for Future Selection of Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) for Radium-223 Treatment.

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Radium-223 is an established radionuclide therapy for patients with metastatic castration resistant prostate cancer (mCRPC) and symptomatic bone metastasis. Patients are eligible for this treatment when they have mCRPC and bone metastases; limited extraskeletal lesions (local prostate, lymph nodes \<3 cm) on conventional contrast enhanced CT (ceCT) were allowed in the registration trial(1). Previous research revealed that extraskeletal disease on ceCT and bone scans correlates with a poor response. Meanwhile, 68Ga-PSMA-PET/CT emerged as more sensitive imaging strategy that increases the detection of extraskeletal prostate cancer metastases. It is unclear whether these extraskeletal lesions harbour any predictive value in the treatment of mCRPC patients with Radium-223.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed adenocarcinoma of the prostate.

• Progressive disease after previous treatment defined as a rise in serum (Prostate Specific Antigen) PSA (PCWG3 criteria(22), see appendix 1) and/or progression on conventional imaging (PCWG3).

• A positive bone scan (osteoblastic bone metastases), with at least two metastases.

• Hemoglobin concentration \>10 g/dl (6.2 mmol/l) and thrombocytes \>100 109/I at baseline.

• Each patient will need to (continue to) receive adequate bone protective agents (e.g. bisphosphonates) and androgen deprivation therapy (ADT) according to current clinical guidelines.

Locations
Other Locations
Netherlands
Meander Medisch Centrum
RECRUITING
Amersfoort
NKI-AVL
RECRUITING
Amsterdam
Sint Antonius ziekenhuis
RECRUITING
Nieuwegein
Diakonessenhuis
NOT_YET_RECRUITING
Utrecht
UMC
RECRUITING
Utrecht
Contact Information
Primary
J.C. van der Mijn, Dr.
k.vd.mijn@nki.nl
+31205129111
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 60
Treatments
Other: mCRPC patients with bone-only disease according to 68Ga-PSMA-PET/CT
a prospective clinical study in which patients with mCRPC and bone-only disease according to ceCT and bone scan will receive standard-of-care treatment with Radium-223. In addition to standard-of-care systemic treatment, each patient will undergo an additional 68Ga-PSMA-PET/CT scan at baseline and will be followed throughout the treatment with online patient reported outcome measure (PROM) questionnaires (Kaiku application) and blood sampling for circulating tumor DNA (ctDNA) analysis.
Related Therapeutic Areas
Sponsors
Collaborators: Bayer
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov