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NCT02572284

Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

Completed Phase 1 Last updated 19 January 2023
What this trial tests

Phase 1 trial testing Stereotactic Body Radiation Therapy (SBRT) in Prostate Cancer in 7 participants. Completed in 23 October 2019.

Timeline
27 January 2016
Primary endpoint
5 July 2018
23 October 2019

Quick facts

Lead sponsorH. Lee Moffitt Cancer Center and Research Institute
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment7
Start date27 January 2016
Primary completion5 July 2018
Estimated completion23 October 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other trials of Stereotactic Body Radiation Therapy (SBRT)

Trials testing the same drug.

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

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