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Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

S

San Diego Radiosurgery

Status and phase

Unknown
Phase 1

Conditions

Prostate Cancer

Treatments

Radiation: Stereotactic Radiosurgery using the Novalis Tx

Study type

Interventional

Funder types

Industry

Identifiers

NCT00969202
SDRS0001

Details and patient eligibility

About

The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.

The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.

Enrollment

50 estimated patients

Sex

Male

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed adenocarcinoma of the prostate
  • Gleason score ≤ 6 and low volume Gleason 7 (3+4)
  • PSA < 10
  • Clinical Stage of T2a or less
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

  • Prior radiation treatment for prostate cancer
  • Gleason score > 7
  • PSA > 10
  • Clinical Stage of T2b or greater

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Stereotactic Radiosurgery using NovalisTx
Experimental group
Description:
Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.
Treatment:
Radiation: Stereotactic Radiosurgery using the Novalis Tx

Trial contacts and locations

1

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Central trial contact

Jennifer Joiner; Jeremy Legg

Data sourced from clinicaltrials.gov

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