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NCT02572284
Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer
Phase 1 trial testing Stereotactic Body Radiation Therapy (SBRT) in Prostate Cancer in 7 participants. Completed in 23 October 2019.
5 July 2018
Quick facts
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 27 January 2016 |
| Primary completion | 5 July 2018 |
| Estimated completion | 23 October 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Stereotactic Body Radiation Therapy (SBRT) — full drug profile →
- Prostatectomy
- Quality of Life Questionnaires
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Oncologic Impact and Safety of Pre-Operative Radiotherapy in Localized Prostate and Bladder Cancer: A Comprehensive Review from the Cancerology Committee of the Association Française d'Urologie.
Sargos P, Supiot S, Créhange G, Fromont-Hankard G, et al · · 2021 · cited 2× · PMID 34885179 · DOI 10.3390/cancers13236070 -
Phase I dose escalation trial of stereotactic radiotherapy prior to robotic prostatectomy in high risk prostate cancer.
Liveringhouse C, Sim A, Yamoah K, Poch M, et al · · 2021 · PMID 34211768 · DOI 10.5603/rpor.a2021.0027
Verify or expand the search:
- PubMed search for NCT02572284
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07258147 — Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases · Phase 2 · not yet recruiting
- NCT07530172 — Radioembolization Versus External Radiation Therapy · Phase 2 · recruiting
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Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
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- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
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- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other H. Lee Moffitt Cancer Center and Research Institute 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 NCT02572284 (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 H. Lee Moffitt Cancer Center and Research Institute
- Last refreshed: 19 January 2023
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/NCT02572284.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing