NCT01956058

✓ Unanimous Initial: outpatient Requery: outpatient — The intervention (brachytherapy remedial) involves patients visiting the clinic for treatment and not being admitted to a hospital, indicating an outpatient setting. Thinking: outpatient — The salvage prostate brachytherapy (with gel injection) is described as a procedural radiation treatment without mention of hospital admission, implying patients come for the procedure and are followed in clinic thereafter.

✓ Unanimous Initial: inpatient Requery: inpatient — The intervention involves brachytherapy, a surgical procedure requiring anesthesia, and explicitly mentions an injection of hyaluronic acid gel 'after surgery,' indicating patients are admitted for this invasive treatment.

✓ Unanimous Initial: outpatient Requery: outpatient — Brachytherapy is typically performed as an outpatient procedure where patients come in for the treatment and then go home the same day, without requiring hospitalization or overnight stays. Thinking: outpatient — Brachytherapy remedial is delivered as an outpatient procedure with patients returning for follow-up visits every 3-6 months, not requiring hospitalization.

✓ Unanimous Initial: no Requery: no — The experimental intervention in this trial is brachytherapy remedial with an injection of hyaluronic acid gel, which involves radiation and a non-pharmacologic material (hyaluronic acid), not a drug or medication.

✓ Unanimous Initial: yes Requery: no — The experimental intervention is brachytherapy, a form of radiation therapy, combined with an injection of hyaluronic acid gel, neither of which is a systemic drug or pharmacologic medication.

✓ Unanimous Initial: no Requery: no — The intervention is brachytherapy (radiation therapy) combined with hyaluronic acid gel injection, which are medical devices/procedures rather than pharmacologic agents.

✓ Unanimous Initial: yes Requery: no — The intervention combines brachytherapy with an injection of hyaluronic acid, both of which are under the same category of local treatments; it does not combine distinct components from different intervention categories.

✓ Unanimous Initial: yes Requery: no — The intervention combines brachytherapy (radiation) with hyaluronic acid gel injection as a single integrated procedure to protect the rectum, representing a single-modality treatment approach rather than multiple distinct interacting components.

✓ Unanimous Initial: no Requery: no — This is a single radiation therapy intervention (brachytherapy with hyaluronic acid gel injection for tissue protection), which represents one treatment modality despite having two technical components that work together for the same radiotherapeutic purpose.

✓ Unanimous Initial: yes Requery: no — The primary and secondary outcomes focus on toxicity, survival, and quality of life, but do not directly measure specific symptoms using validated symptom instruments like ESAS, MSAS, or PHQ-9.

✓ Unanimous Initial: yes

✓ Unanimous Initial: no Requery: no — While the study measures urinary and sexual toxicities using questionnaires (IIEF-5, IPSS, QLQ-C30, EPIC), these are not validated symptom-specific instruments but rather function/QoL measures, and the primary outcome focuses on toxicity occurrence rather than symptom assessment.

✓ Unanimous Initial: N/A Requery: N/A — The intervention in this trial is radiation therapy (brachytherapy), which is not pharmacologic.

✓ Unanimous Initial: other Requery: N/A — The intervention in this clinical trial is brachytherapy, which is a form of radiotherapy (classified under radiation) and not a pharmacologic drug.

✓ Unanimous Initial: N/A Requery: N/A — The intervention is brachytherapy (radiation therapy) with hyaluronic acid gel injection, which is a radiation-based treatment rather than a pharmacologic intervention.