Clinical trial NCT05735652: An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel
Official title: An Observational Study to Evaluate the Safety and Effectiveness of Radiotherapy for Localized T1-T2 Prostate Cancer in China After Injection of SpaceOAR Hydrogel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 14
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: During screening, patients who have received or will receive radiotherapy will be identified.

These who have been injected with SpaceOAR hydrogel will be enrolled. For patients who have already received radiotherapy, the clinical data can be collected retrospectively, and informed consent will be performed (If follow up visits can be conducted prospectively). For patients who will receive radiotherapy, informed consent will be gained.

Brief summary: This observational study aims to evaluate the safety and effectiveness of radiotherapy for subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel, via collecting clinical data related to radiotherapy.

Detailed description: This study protocol is for the second part of SpaceOAR real world study in which long term follow-up visits will be performed (up to 1 year) outside Boao Medical Tourism Pilot Zone. The SpaceOAR real world study is a retrospective and prospective, single arm, observational study (Ptotocol of SpaceOAR RWS Windchill#: 92743236). Subjects with localized T1-T2 prostate cancer who have already been injected with the SpaceOAR and have received radiotherapy or will receive radiotherapy will be enrolled, and clinical data related to radiotherapy will be collected. For subjects who have already completed radiotherapy before study kick-off, clinical data will be collected retrospectively, such as data related to radiotherapy, AE (if any) and MRI (if any). Follow up vist will be completed if applicable. For subjects who receive therapy after study kick-off, follow up visits at 2 weeks, 6weeks, 3 months and 10 months after radiotherapy will be scheduled to assess bowel, urinary and sexual function and quality of life.

Eligibility criteria: Inclusion Criteria:

* Subjects have provided the written informed consent, are willing to participate in clinical data collection and willing to comply with study procedure. (for subjects enrolled prospectively)
* Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated with Space OAR Hydrogel, and have received or will receive radiotherapy.

Exclusion Criteria:

* All subjects have received radiotherapy or will receive radiotherapy, who have injected with SpaceOAR hydrogel in Boao Medical Pilot Zone.
* There is no specific exclusion criteria unless the patients refuse to sign the informed consent.

Primary outcomes:
measure: Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection.
timeFrame: Post injection gel surgery 1-10 days
Secondary outcomes:
measure: Urinary, Bowel and Sexual Function Assessment Score
timeFrame: After the completion of radiotherapy, the month 3 Expanded Prostate Cancer Index Composite (EPIC)-26 score was compared to the baseline EPIC-26 score.
measure: Quality of Life Was Measured by EQ-5D-5L Scale（the Five-level Version of the EuroQol 5-Dimension Scale)
timeFrame: After the completion of radiotherapy, the month 3 EQ-5D-5L scale（the five-level version of the EuroQol 5-Dimension scale) score was compared to the baseline EQ-5D-5L scale score.
measure: The Distance Between Prostate and Rectum
timeFrame: After the completion of radiotherapy, the weeks 6 the distance between prostate and rectum measured by MRI was compared to the baseline the distance between prostate and rectum measured by MRI.
measure: the Distance Between the Prostate and Rectum
timeFrame: After the completion of radiotherapy, the month 10 the distance between prostate and rectum measured by MRI was compared to the baseline the distance between prostate and rectum measured by MRI.
measure: Adverse Event Related to SpaceOAR Hydrogel (Safety)
timeFrame: Through the entire study phase until 10 months after the completion of radiotherapy.
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
Study officials:
affiliation: Hospital Executive
name: Nianzeng Xing, Doctor
role: PRINCIPAL_INVESTIGATOR
References: