NCT06927635

Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial

Extracted Fields (from Registry)
Protocol IDNCT06927635
Registration Date2025-04-15
Statusrecruiting
SponsorUniversity Health Network, Toronto
CountryCanada
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2025-07-08
Last Patient Out2030-06-01
Publicationn
Gender %MALE
Mean Age18 Years - 100 Years
LLM Classifications (Side-by-Side)
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
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