Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer (NCT07717099) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer
Spain50 participantsStarted 2026-09
Plain-language summary
GUARD-QUANTUM is a prospective, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study. The rationale behind studying this combination lies in the potential additive or synergistic benefits that may arise from concurrently targeting androgen receptor signaling pathways and bone metastases.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must be fully informed about the study and sign the informed consent form (ICF) before any study specific assessment.
. Patients ≥18 years old.
. ECOG performance status of 0 to 2 and Charlson score ≤ 3 prior to study entry, after docetaxel.
. Patients with histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
. Patients should have received triplet therapy with ADT (luteinizing hormone releasing hormone analogue (LHRHA) for continuous treatment or previous bilateral orchidectomy), docetaxel and darolutamide as first-line therapy for mHSPC. The following conditions apply:
. Received ≥ 4 cycles of docetaxel.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment compliance
Timeframe: Throughout the study treatment period, approximately 6 months
Trial details
NCT IDNCT07717099
SponsorAlianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
. Treatment with docetaxel should be finished ≤ 12 weeks before the first planned dose of Ra223.
. Having no progression of the disease after triplet therapy completion and before inclusion.
Exclusion criteria
. Presence of tumor lesion in central nervous system through radiologically confirmed diagnosis.
. Prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin, in-situ carcinoma or low-grade superficial bladder cancer, or the patient has been free of malignancy for a period of 3 years prior to inclusion).
. Patients experiencing progression during previous ADT or meeting criteria for castration resistant prostate cancer (CRPC).
. External irradiation, brachytherapy, or local treatment (including radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.) within 4 weeks prior to the first dose of study treatment.
. Received prior chemotherapy for prostate cancer other than as part of first-line triplet therapy for mHSPC.
. Major surgery within 4 weeks prior to treatment.
. Prior hemibody external radiotherapy.
. Corticosteroids are allowed only at a dose ≤ 10 mg of prednisone (or equivalent) no matter the indication.