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. 2024 Jun 19;9(7):103484. doi: 10.1016/j.esmoop.2024.103484

Table 2.

Metastatic hormone-sensitive prostate cancer

Question Statement Level of consensus
Agree (%) Disagree (%) Uncertain (%)
  • 1.

    Among patients receiving systemic treatment for mHSPC, which are those at risk of fracture?8
  • 1.1

    All patients receiving ADT ± docetaxel ± NHT should be treated with bone-targeting agents for fragility fracture prevention.

 75.4 8.2 16.4
  • 2.

    Are there other independent fracture risk factors to consider when deciding to use drugs for bone health in patients with mHSPC?
  • 2.1

    In mHSPC the independent factors of fracture risk (BMD, familiarity with fragility fractures, corticosteroid therapy with >5 mg/prednisone equivalent in the past for >3 months consecutively or ongoing, metabolic bone diseases or fragilizing disease treatment, disability or high risk of fall, age, anamnesis for low-energy trauma fractures) should be evaluated before starting any antifracture prevention therapy. However, the fracture risk is independent of these factors that are, if present, additive in the risk estimation. Consequently, every patient candidate to treatment for mHSPC should receive bone-protective agents independently of the individual fracture risk.

 78.7 9.8 11.5
  • 3.

    When should antiresorptive therapy be initiated in males treated with systemic treatment for mHSPC?26
  • 3.1

    In mHSPC patients a therapy with antiresorptive drugs at the doses and schedule for SREs prevention should not be started.

 80.3 4.9 14.8
  • 4.

    In males in treatment for mHSPC, when should antiresorptive therapy be started and which drugs and schedules should be used for the prevention of CTIBL and the reduction of the risk of fracture?
  • 4.1

    BTAs should be considered from the start of ADT itself for primary prevention of CTIBL.

 75.4 4.9 19.7
  • 4.2

    In patients with mHSPC on ADT ± chemotherapy ± ARSI for the prevention of risk of fracture, denosumab 60 mg every 6 months is advisable. In case of prescriptive ineligibility to therapy with denosumab and lack of reimbursement, the use of another BTA (alendronate 70 mg weekly, risedronate 35 mg weekly or clodronic acid weekly or zoledronic acid 4 mg every 6 months) might be a choice.

 93.6 3.2 3.2
  • 4.3

    Before starting and during any hormonal therapy, the levels of vitamin D (≥30 ng/ml) should be evaluated and normalized, regardless of the bone-modifying agent. A calcium intake of about 1000 mg/day or administration of calcium element at the equivalent dose and a daily dose of vitamin D 1500-2000 IU during antiresorptive therapy is mandatory.

 90.2 3.3 6.5
  • 5.

    Patients with mHSPC on ADT+ docetaxel and/or NHT: how long should they be treated with antiresorptive drugs for the prevention of the risk of fractures?
  • 5.1

    If no adverse events, antifracture treatment with BTAs should be continued until the diagnosis of castration resistance. After the diagnosis of castration resistance, BTAs should be administered at the same doses and schedule of mCRPC with bone metastases. If no bone metastases occur in mCRPC, the doses and schedule are the same for CTIBL prevention.

 93.6 1.6 4.8
  • 6.

    How to diagnose and monitor the bone health in mHSPC during ADT and docetaxel and/or NHT?
  • 6.1

    mHSPC patients should be monitored for metastatic disease by scintigraphy, CT scan or any other evaluation at physician’s choice. Moreover, bone health monitoring should be carried out in the same way as nmHSPC (monitor the following: vitamin D; serum calcium and PTH; DEXA scan with trabecular bone score, if available; if possible: bone turnover markers; height, weight and BMI and body composition. In case of back pain or height loss, carry out a spine radiography).

 83.6 3.3 13.1
  • 7.

    For patients who are already being treated for previous osteoporosis and who are candidates for ADT and docetaxel and/or NTH for mHSPC, which treatment is recommended?
  • 7.1

    Patients should continue the same treatment for previous osteoporosis, as long as it involves calcium and vitamin D supplementation and BPs (alendronate 70 mg weekly or clodronic acid weekly or zoledronic acid every 6 months) or denosumab 60 mg every 6 months.

 88.5 3.3 8.2
  • 7.2

    Patients mHSPC in treatment with BPs for previous osteoporosis should be switched to denosumab 60 mg every 6 months for prevention of fragility fractures.

 59 18 23

ADT, androgen deprivation therapy; ARSI, androgen receptor signaling inhibitor; BMD, bone mineral density; BMI, body mass index; BPs, bisphosphonates; BTAs, bone-targeting agents; CT, computed tomography; CTIBL, cancer treatment-induced bone loss; DEXA, dual-energy X-ray absorptiometry; mCRPC, metastatic castration-resistant prostate cancer; mHSPC, metastatic hormone-sensitive prostate cancer; NHT, new hormone therapies; nmHSPC, non-metastatic hormone-sensitive prostate cancer; PTH, parathyroid hormone; SREs, skeletal-related events.