Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer

Starting soon · Phase 2

Conditions studied: Metastatic Hormone-Sensitive Prostate Cance

In brief

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.

Key facts

Study ID

NCT07717099

Run by

Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD

People needed

50

Starts

2026-09-01

Expected to finish

2029-12-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must fulfill all of the following inclusion criteria to be eligible for enrollment to the study:
• 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.
• 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.
• Note: patients with prior therapies for locoregional disease are acceptable
• Patients should have recovered from any prior toxicity from ADT, darolutamide or docetaxel to CTCAE grade 1 or baseline levels.
• Presence of at least 4 bone metastasis on the screening bone scan, with or without lymph node and/or visceral metastases.
• Asymptomatic or mildly symptomatic (defined as short form question #3 in Brief Pain Inventory worst pain must be < 4).
• Patients should be willing to initiate or continue bisphosphonates /denosumab, calcium and vitamin D supplements (Section 7.4.4) prior to the first dose of Ra223.
• Note: Patients must start treatment with a bone protecting agent (at doses used to reduce the incidence of skeletal related events) before the time of signing the ICF. A minimum of two doses is recommended before the first administration of Ra223. The first administration of Ra223 should be scheduled at least 6 weeks after the first administration of the bone protecting agent.
• T-score ≥ -2.5 on a DXA scan done in the past 12 months. A DXA scan performed during the screening period will be encouraged but not mandated.
• Adequate organ and bone marrow function as follows (subject must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory):
• Absolute neutrophil count (ANC) ≥ 1.5 x109/L;
• Platelets ≥ 100 x109/L;
• Hemoglobin ≥ 9.0 g/dl;
• Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN), except for patients with Gilbert's disease ≤ 5.0 x ULN;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;
• Creatinine ≤ 1.5 x ULN;
• CrCl < 30 mL/min;
• Albumin > 25 g/L.

You may not qualify if…

• Subjects with any of the following could not enroll in this study:
• 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).
• Note: Prior ADT is allowed.
• 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.
• Receiving abiraterone treatment as part of the first-line triplet therapy for mHSPC.
• Note: An increased risk of death and fractures was observed in a clinical study in which Ra223 was added to abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic CRPC and this is the rationale to not include patients with this combination.
• Plan to receive any other antitumor therapies during this trial.
• Treatment with an investigational drug within the previous 4 weeks, or planned during the treatment period.
• Any other serious illness or medical condition such as, but not limited to:
• Any uncontrolled infection ≥ Grade 2 according to NCI-CTCAE v6.0;
• Gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease);
• Crohn's disease or ulcerative colitis;
• Osteonecrosis of the jaw;
• Non-malignant bone disease with an osteoblastic activity;
• Bone marrow dysplasia;
• Fecal incontinence;
• Life-threatening illness unrelated to cancer.
• Significant cardiovascular disease including:
• Uncontrolled angina within 3 months prior to screening;

Where it is running

• Hospital Clínic de Barcelona — Barcelona, Spain
• Hospital Santa Creu i Sant Pau — Barcelona, Spain
• Complejo Hospitalario Universitario Materno-Infantil de Gran Canaria (CHUIMI) — Las Palmas de Gran Canaria, Spain
• Hospital Clínico San Carlos — Madrid, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Hospital Universitario La Paz — Madrid, Spain
• Hospital Universitario HM Sanchinarro — Madrid, Spain
• Hospital Universitario Central de Asturias (HUCA) — Oviedo, Spain
• Hospital Universitario Marqués de Valdecilla — Santander, Spain
• Complejo Hospitalario Universitario de Santiago (CHUS) — Santiago de Compostela, Spain
• Instituto Valenciano de Oncología (IVO) — Valencia, Spain
• Hospital Clínico Universitario de Valladolid (HCUV) — Valladolid, Spain

Full record on ClinicalTrials.gov

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