Introduction
Materials and methods
Results
N
| Unanimity | Strong consensus | Consensus | No Consensus | |
---|---|---|---|---|---|
N (%) | N (%) | N (%) | N (%) | ||
Topic 1—CRPC definition | 2 | 100.0% | |||
Topic 2—Symptomatic patients | 8 | 25.0% | 62.5% | 12.5% | |
Topic 3—Diagnosis of metastasis | 30 | 3.3% | 96.7% | ||
Topic 4—CRPC progression | 21 | 23.8% | 66.7% | 9.5% | |
Topic 5—M0 management | 6 | 50.0% | 50.0% | ||
Topic 6—M1 management and sequencing therapy | 29 | 24.1% | 62.1% | 3.5% | 10.3% |
Topic 7—Treatment monitoring | 20 | 20.0% | 75.0% | 5.0% | |
116 | 22 (19%) | 86 (74.1%) | 3 (2.6%) | 5 (4.3%) |
Yes | No | Consensus level | ||
---|---|---|---|---|
Topic 1—CRPC definition | ||||
In patients with castrate levels of testosterone, CRPC can be defined as: | ||||
Confirmed PSA progression (> 2 ng/ml) and/or radiological progression |
96%
| 4% | SC | |
Confirmed PSA progression (> 2 ng/ml) and/or radiological progression after ≥ 2 prior hormonal therapies | 12% |
88%
| SC | |
Topic 2—Symptomatic patients | ||||
Criteria to define a minimally symptomatic patient | ||||
Low score on validated pain scales |
100%
| 0% | U | |
Pain response to NSAID/paracetamol |
100%
| 0% | U | |
Pain control by opioids | 12% |
88%
| SC | |
Previous response to antalgic radiotherapy |
80%
| 20% | SC | |
Scales used to assess the patient’s pain: | ||||
BPI–SF (Brief Pain Inventory – Short Form) |
92%
| 8% | SC | |
Visual analogic scale |
96%
| 4% | SC | |
Subjective patient assessment/verbal scales | 28% |
72%
| MC | |
Scales are not important in evaluating patient pain | 4% |
96%
| SC | |
Topic 3—Diagnosis of metastasis | ||||
Bone scan (BS) | ||||
In a CPRC patient, a BS would be appropriate to perform in the following scenarios: | ||||
At CRPC diagnosis, regardless of PSA levels |
88%
| 12% | SC | |
When PSA level is > 10 ng/ml and/or PSA-DT at < 6 months |
92%
| 8% | SC | |
At the onset of bone pain |
92%
| 8% | SC | |
Given a negative BS in an asymptomatic M0 CRPC patient, the test would be repeated under the following circumstances: | ||||
PSA level of > 10 ng/ml and/or PSA-DT at < 6 months |
92%
| 8% | SC | |
PSA level of > 2 ng/ml and/or PSA-DT at 6–12 months | 16% |
84%
| SC | |
Every 3–6 months regardless of PSA values |
20%
|
80%
| SC | |
Exclusively with the onset of pain | 16% |
84%
| SC | |
In a CPRC patient with bone pain, in the event of a negative/inconsistent BS: | ||||
Wait to know what the PSA kinetics are | 12% |
88%
| SC | |
An additional imaging test is required (standard x-rays of areas of concern, axial skeleton MRI scan, CT bone scan or choline PET/CT) |
92%
| 8% | SC | |
CT Scan | ||||
In a CPRC patient, a chest, abdomen and pelvis CT scan would be appropriate to perform: | ||||
At CRPC diagnosis, regardless of PSA levels |
96%
| 4% | SC | |
With a PSA level of > 10 ng/ml and/or PSA-DT at < 6 months |
88%
| 12% | SC | |
At the onset of metastatic related symptoms |
96%
| 4% | SC | |
In a CPRC M0 asymptomatic patient, with a negative CT scan, the following test should be repeated: | ||||
With a PSA level of > 10 ng/ml and/or PSA-DT at < 6 months |
96%
| 4% | SC | |
With a PSA level of > 2 ng/ml and/or PSA-DT at 6–12 months | 16% |
84%
| SC | |
Every 3–6 months regardless of PSA values | 16% |
84%
| SC | |
Only if they present symptoms | 16% |
84%
| SC | |
In a symptomatic CPRC patient, in the event of a negative/inconsistent CT Scan: | ||||
Wait to know what the PSA kinetics are | 12% |
88%
| SC | |
An additional imaging test is required (whole-body MRI or choline PET/CT) |
100%
| 0% | U | |
Choline PET/CT/Whole-body MRI | ||||
Performing PET/CT would be appropriate for CRPC patients: | ||||
In order to confirm inconclusive M1 test results |
88%
| 12% | SC | |
Following a negative conventional cancer staging study (CT and BS) | 12% |
88%
| SC | |
Following a negative conventional cancer staging study (CT and BS) and aggressive PSA kinetics |
96%
| 4% | SC | |
Performing a whole-body MRI would be the best option for CRPC patients: | ||||
In order to confirm inconclusive M1 test results |
100%
| 0% | U | |
Following a negative conventional cancer staging study (CT and BS) | 20% |
80%
| SC | |
Following a negative conventional cancer staging study (CT and BS) and aggressive PSA kinetics |
80%
| 20% | SC | |
Oligometastatic CPRC patient | ||||
Definition criteria: | ||||
Lack of visceral disease | 8% |
92%
| SC | |
Ganglionic and/or bone disease (5 areas or fewer) |
92%
| 8% | SC | |
Images needed in order to diagnose the oligometastatic CPRC patient: | ||||
CT and BS |
84%
| 16% | SC | |
Choline PET/CT |
88%
| 12% | SC | |
Whole-body MRI |
80%
| 20% | SC | |
Do you agree with the following statement? | ||||
Choline PET/TC is not useful to identify oligometastasis in patients with a low PSA level (≤ 1 ng/ml) |
96%
| 4% | SC | |
Topic 4—CRPC progression | ||||
Do you agree that the following statements define the progression of a CPRC patient? | ||||
Exclusive biochemical progression | 12% |
88%
| SC | |
Radiological progression |
96%
| 4% | SC | |
Clinical progression (pain, overall status) |
88%
| 12% | SC | |
Which statements define primary resistance to therapies targeting the androgen receptor pathway (enzalutamide/abiraterone): | ||||
Absence of decline in PSA level (≥ 30%) during the first 3 months | 12% |
88%
| SC | |
Sustained PSA progression within 3–4 months of therapy initiation | 68% | 32% | NC | |
Radiological progression within 3–4 months of therapy initiation |
92%
| 8% | SC | |
Statements related to the flare-up occurrence | ||||
A flare-up is defined as a temporary clinical and/or biochemical worsening since therapy initiation |
92%
| 8% | SC | |
A flare-up occurs with taxane treatment |
100%
| 0% | U | |
A flare-up occurs with enzalutamide treatment | 56% | 44% | NC | |
A flare-up occurs with abiraterone treatment |
100%
| 0% | U | |
The following parameters are predictive factors of poor response to therapies: | ||||
High primary tumour Gleason score |
100%
| 0% | U | |
Short response duration after first-line hormonal therapy (LHRH) |
96%
| 4% | SC | |
Presence of visceral metastasis |
100%
| 0% | U | |
Short PSA-DT | 96% | 4% | SC | |
High LDH and/or alkaline phosphatase |
92%
| 8% | SC | |
Moderate to severe pain score |
92%
| 8% | SC | |
Overall poor condition (ECOG performance status) |
100%
| 0% | U | |
The following parameters are prognostic factors of disease progression: | ||||
Presence of circulating tumour cells (≥ 5/7.5 ml) |
84%
| 16% | SC | |
Presence of androgen receptor splice variant (AR-V7) |
92%
| 8% | SC | |
Do you agree with the following definition of the biochemical progression of the CPRC patient? | ||||
Three consecutive PSA increases one week apart, resulting in two 50% increases over the nadir and a PSA level of > 2 ng/ml |
88%
| 12% | SC | |
Three consecutive PSA increases one week apart, resulting in two 50% increases over the nadir and a PSA level of > 1 ng/ml | 12% |
88%
| SC | |
Topic 5—M0 management | ||||
In an M0 CRPC patient, do you agree with the following statements? | ||||
An initial BS should be requested for PSA levels of > 2 ng/ml |
84%
| 16% | SC | |
For PSA levels of > 2 ng/ml and negative BS, the test should be repeated when PSA levels reach ≥ 5 ng/ml |
88%
| 12% | SC | |
For PSA levels of ≥ 5 ng/ml and negative BS, the test should be repeated each time the PSA level doubles and PSA should be tested every 3 months |
88%
| 12% | SC | |
In an M0 CRPC patient with local clinical progression, the first-line therapy would be: | ||||
Radiotherapy (if no prior RT) or salvage surgery |
100%
| 0% | U | |
Docetaxel | 0% |
100%
| U | |
New antiandrogen therapies (enzalutamide/abiraterone) | 0% |
100%
| U | |
Topic 6—M1 management and sequencing therapy | ||||
In an asymptomatic/minimally symptomatic M1 CRPC patient the first-line therapy would be: | ||||
Enzalutamide/abiraterone in most cases |
100%
| 0% |
U
| |
Docetaxel in most cases | 0% |
100%
|
U
| |
Docetaxel in some aggressive cases |
92%
| 8% |
SC
| |
In an initially asymptomatic or minimally symptomatic M1 CRPC patient, the following factors would influence the choice of treatment: | ||||
Visceral metastases |
96%
| 4% |
SC
| |
Hypertension | 44% | 56% |
NC
| |
History of cardiovascular disease |
72%
| 28% |
MC
| |
History of seizures |
80%
| 20% |
SC
| |
Contradindications for steroid use |
96%
| 4% |
SC
| |
In an asymptomatic/minimally symptomatic M1 CRPC patient with visceral metastasis, first-line therapy would be: | ||||
Enzalutamide |
80%
| 20% | SC | |
Abiraterone | 0% |
100%
| U | |
Docetaxel | 20% |
80%
| SC | |
In an asymptomatic/minimally symptomatic M1 CRPC patient, secondary hormonal manipulations | ||||
Are suitable for patients who are not candidates for chemotherapy only when enzalutamide/abiraterone are not available |
88%
| 12% | SC | |
Are suitable for patients who are not candidates for chemotherapy regardless of enzalutamide/abiraterone availability | 0% |
100%
| U | |
Are suitable for all patients, regardless of whether they are chemotherapy candidates or not | 4% |
96%
| SC | |
If there is progression… | ||||
A biopsy of the metastatic lesion would be performed to check for a change in the tumour phenotype. | 52% | 48% | NC | |
In a symptomatic M1 CRPC patient the first-line therapy would be: | ||||
New antiandrogenic drugs (enzalutamide/abiraterone) | 16% |
84%
| SC | |
Docetaxel |
84%
| 16% | SC | |
Radium-223 (in bone/non-visceral metastases) |
92%
| 8% | SC | |
Do you agree with the following statement? | ||||
Most CPRC with symptomatic bone metastases should be treated with bone-targeting therapies (bisphosphonate, denosumab, if there areno contraindications). |
88%
| 12% | SC | |
If you answered yes to the previous question, the bone-targeting therapies must be continued: | ||||
For 12–24 months | 55% | 45% | NC | |
Until the onset of bone progression |
82%
| 18% | SC | |
The local control of oligometastasis… | ||||
Decreases symptoms. |
92%
| 8% | SC | |
Delays the start of a new systemic treatment |
88%
| 12% | SC | |
Increases overall/progression-free survival |
84%
| 16% | SC | |
In oligometastatic CPRC patients… | ||||
Local ablative therapy in addition to the new antiandrogenic drugs (enzalutamide/abiraterone) must be considered |
92%
| 8% | SC | |
A radical prostate treatment should be performed |
100%
| 0% | U | |
In the CPRC patient the following supportive therapies must be offered: | ||||
Calcium and vitamin D when denosumab or bisphosphonates are prescribed |
96%
| 4% | SC | |
External radiotherapy, radiopharmaceuticals and analgesia in cases of painful bone metastases |
100%
| 0% | U | |
Corticosteroids and surgical evaluation and radiation in patients with spinal cord compression |
100%
| 0% | U | |
Topic 7—Treatment monitoring | ||||
Imaging test suitable to evaluate bone metastasis response to the therapy | ||||
Tc-99 m bone scan |
84%
| 16% | SC | |
Whole body MRI and/or axial skeleton |
92%
| 8% | SC | |
Choline PET/TC |
84%
| 16% | SC | |
In an asymptomatic/minimally symptomatic CPRC patient, does the first-line therapy choice influence the frequency of patient monitoring in the following? | ||||
Follow-up patient visits |
100%
| 0% | U | |
Imaging tests frequency | 4% |
96%
| SC | |
Analytic testing |
84%
| 16% | SC | |
Additional blood pressure monitoring |
80%
| 20% | SC | |
If you answered yes, which is your preferred choice of action during the first 3 months of enzalutamide therapy: | ||||
1/2 weeks | Monthly | Quarterly | ||
Frequent follow-up visits | 4% |
80%
| 16% | SC |
Imaging tests frequency | 14% |
84%
| 12% | SC |
Analytic testing | 10% |
70%
| 20% | MC |
If you answered yes, which is your preferred choice of action during the first 3 months of abiraterone therapy: | ||||
1/2 weeks | Monthly | Quarterly | ||
Frequent follow-up visits |
92%
| 8% | 0% | SC |
Analytic testing |
84%
| 16% | 0% | SC |
Additional blood pressure monitoring |
85%
| 15% | 0% | SC |
In an asymptomatic/minimally symptomatic M1 CPRC patient, follow-up tests must be performed: | ||||
Every 3–6 months, regardless of PSA values |
88%
| 12% |
SC
| |
When the PSA values double |
96%
| 4% |
SC
| |
In the event of symptoms related to the metastatic disease appearing |
100%
| 0% |
U
| |
In a symptomatic M1 CPRC patient, follow-up tests must be performed: | ||||
Every 3 months, regardless of PSA values |
84%
| 16% |
SC
| |
Every 6 months, regardless of PSA values | 4% |
96%
|
SC
| |
When the PSA values double |
96%
| 4% |
SC
| |
In the event of new symptoms appearing |
100%
| 0% |
U
|