Clinical trial · Interventional

CyberKnife Radiosurgery for Localized Prostatic Carcinoma

Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study

NCT01045148CI-TRIAL-00028727unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. As such, it is a more "patient friendly" treatment method compared with actual prostate HDR brachytherapy as currently practiced. Related, as has previously been reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
CyberKnife Radiosurgery	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
OTHER
label
CyberKnife Radiosurgery
description
CyberKnife Radiosurgery
interventionNames
1. Radiation: CyberKnife Radiosurgery

Primary outcomes (1)

measure
To evaluate the effects of CK prostate radiosurgery in terms of morbidity/QOL, relative to other commonly used methods of prostate cancer treatment and the pattern of PSA decline and biochemical relapse-free survival thereafter.
timeFrame
5 years

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b (AJCC 6th Edition, see Appendix II), NX/N0, M0.
* Karnofsky performance status \> 80.
* Patient must be ≥ 18 years of age.

  * Gleason Sum \< or = 7
  * Prostate-specific antigen \< or = 20 ng/ml
* Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

* Stage \< T1b, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix II).
* Gleason Score \> 7.
* PSA \> 20 ng/ml.
* Lymph node involvement (N1).
* Evidence of distant metastases (M1).
* Radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical clips or other metallic foreign bodies.
* History of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three months prior to treatment).
* Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
* Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
* Metallic Hip prosthesis.
* History of inflammatory bowel disease

References

Publications (1)

DERIVEDDe Bari B, Daidone A, Alongi F. Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. Crit Rev Oncol Hematol. 2015 Jun;94(3):360-70. doi: 10.1016/j.critrevonc.2015.02.003. Epub 2015 Feb 17. PMID 25819287

Registry

Dates and enrollment

Start: Mar 1, 2006
Primary completion: Dec 1, 2020
Completion: —
First posted: Jan 8, 2010
Last update posted: Jul 21, 2017
Enrollment: 258 (estimated)
Lead sponsor: CyberKnife Centers of San Diego OTHER
Keywords: Prostatic Cancer, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate

Data updated 22 days agoSource updated Jul 21, 2017source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.