| Protocol ID | NCT04115007 |
| Registration Date | 2019-10-03 |
| Status | active, not recruiting |
| Sponsor | UNICANCER |
| Country | France, Martinique |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | multinational RCT |
| First Patient In | 2020-06-23 |
| Last Patient Out | 2031-02-28 |
| Publication | n |
| Gender % | MALE |
| Mean Age | 18 Years - |
NCT04115007
Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients - a GETUG-AFU Phase III Randomized Controlled Trial
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5307ms / 12241 tok |
OPENAI
gpt-4o Thinking: o3 3148ms / 10491 tok |
GLM
glm-5.1 8310ms / 10672 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This is a multicenter trial delivering stereotactic radiotherapy (SBRT) to oligometastases at 35 sites, which would typically be delivered in outpatient oncology/radiation therapy facilities rather than requiring hospitalization.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention (Stereotactic Body Radiotherapy) is delivered as an outpatient procedure to oligometastatic sites and not requiring hospital admission, indicating outpatient or community settings.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — Radiotherapy treatments for outpatients in this multicenter phase III trial are delivered in ambulatory care settings or outpatient clinics.
|
OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The experimental intervention is stereotactic body radiotherapy (SBRT) to oligometastases, which is a radiation therapy technique, not a drug or medication.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The experimental intervention only involves stereotactic body radiotherapy, not a drug/medication.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The experimental intervention being tested is ablative stereotactic radiotherapy (SBRT), which is a radiation procedure, not a pharmacologic drug.
|
OK |
| intervention_chemo_immuno_radio | yes | yes | yes | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
yes
yes → yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The experimental arm combines multiple distinct treatment modalities: stereotactic body radiotherapy (SBRT) to oligometastases plus standard of care which includes radiotherapy to prostate/lymph nodes, androgen deprivation therapy, and potentially additional hormonal therapy or chemotherapy - representing a multicomponent intervention with radiation, pharmacologic, and potentially chemotherapy components working together.
Thinking: no — The trial tests adding a single intervention type (SBRT radiation) to standard care, not multiple interacting components from different categories.
|
no
no → no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: no — The trial involves combining stereotactic radiotherapy with standard prostate cancer care treatments, which are within the same radiotherapeutic category, thus not meeting the multi-category complexity requirement.
Thinking: yes — Experimental arm delivers SBRT (radiation) in conjunction with the usual pharmacologic/hormonal ± chemotherapy standard-of-care, thus integrating two distinct treatment categories.
|
no
no → no
shaky reasoning✗ No consensus
Initial: no
Requery: no — The intervention evaluates a single treatment modality (stereotactic radiotherapy) added to standard of care.
|
|
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | yes | yes | yes | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub |
N/A
other → N/A
shaky reasoning✓ Unanimous
Initial: other
Requery: N/A — The intervention is stereotactic body radiotherapy (SBRT) which is a radiation-based treatment, not a pharmacologic intervention.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The primary intervention is stereotactic radiotherapy, which is not pharmacologic.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The primary intervention being evaluated in this clinical trial is Stereotactic Body Radiotherapy (SBRT), which is a non-pharmacologic procedure.
|
OK |