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NCT05224869
Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer
NA trial testing Medical Device Usage and Evaluation in Prostate Cancer in 10 participants. Terminated before completion.
29 January 2025
Quick facts
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 31 August 2021 |
| Primary completion | 29 January 2025 |
| Estimated completion | 29 January 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Medical Device Usage and Evaluation
- CT simulation
- Stereotactic body radiation therapy — full drug profile →
- Brachytherapy — full drug profile →
- Post-implant dosimetry scan
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Icahn School of Medicine at Mount Sinai
Who can join
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies the effect of rectal spacer hydrogel before radiation therapy in reducing radiation dose to the rectum in patients with prostate cancer. Rectal spacer hydrogen is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The rectal spacer gel is made up of 90% water and 10% polyethylene glycol and is injected as a liquid through a needle inserted between the rectum and prostate. It stays in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months. By pushing the prostate further from the rectum with the hydrogel, it may help spare the rectum from receiving radiation during standard of care stereotactic body radiation therapy and brachytherapy treatment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Next-Generation 3D Scaffolds for Nano-Based Chemotherapeutics Delivery and Cancer Treatment.
Shahriar SMS, Andrabi SM, Islam F, An JM, et al · · 2022 · cited 11× · PMID 36559206 · DOI 10.3390/pharmaceutics14122712
Verify or expand the search:
- PubMed search for NCT05224869
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Icahn School of Medicine at Mount Sinai trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05224869 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
- Last refreshed: 26 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05224869.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing