| Protocol ID | NCT06927635 |
| Registration Date | 2025-04-15 |
| Status | recruiting |
| Sponsor | University Health Network, Toronto |
| Country | Canada |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2025-07-08 |
| Last Patient Out | 2030-06-01 |
| Publication | n |
| Gender % | MALE |
| Mean Age | 18 Years - 100 Years |
NCT06927635
Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial
| Field |
GLM
glm-5.1 6426ms / 9072 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 9390ms / 10395 tok |
OPENAI
gpt-4o Thinking: o3 5671ms / 8918 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 — The study involves SBRT, a form of radiation therapy that is typically delivered in an outpatient clinic or ambulatory care setting, without requiring patient hospitalization.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — This is a single-center outpatient radiation therapy study where patients receive SBRT treatments at a medical facility, which represents an outpatient clinical setting rather than requiring hospitalization.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention involves Stereotactic Body Radiotherapy (SBRT) according to institutional standards, likely in a specialized clinic or outpatient setting rather than requiring hospital admission.
|
OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The experimental intervention is Stereotactic Body Radiation Therapy (SBRT), which is a radiation treatment technique, not a drug or medication.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The experimental intervention involves stereotactic body radiotherapy (SBRT), which is not a pharmacologic intervention.
|
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 | no | no | no | OK |
| 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 |
no
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The secondary outcomes include the assessment of toxicity differences between arms using CTCAE v5.0, which is a validated instrument for evaluating adverse events and symptoms.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The primary outcomes focus on feasibility and PSA changes, while secondary outcomes measure disease control, survival, toxicity via CTCAE, and quality of life via EORTC QLQ-C30, but none specifically assess individual symptoms using validated symptom measurement instruments.
Thinking: no — The study uses EORTC QLQ-C30 for quality of life and CTCAE for toxicity grading, but does not include any validated symptom assessment instruments.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The clinical trial does not involve any primary or secondary outcome measures that assess symptoms using symptom-specific instruments.
Thinking: no — The listed outcomes assess PSA, imaging, toxicity (CTCAE), and QoL (EORTC) but include no validated symptom-specific instruments such as pain, fatigue, or mood scales.
|
OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub |
N/A
N/A
shaky reasoning✓ Unanimous
Initial: N/A
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The primary intervention is Stereotactic Body Radiation Therapy (SBRT), which is a form of radiotherapy, not a pharmacologic intervention.
|
N/A
chemotherapy → N/A
shaky reasoning✓ Unanimous
Initial: chemotherapy
Requery: N/A — The intervention in this clinical trial is stereotactic body radiotherapy, which is not pharmacologic.
|
OK |