Status:
ACTIVE_NOT_RECRUITING
CyberKnife Dose Escalation Prostate Cancer Trial
Lead Sponsor:
Crozer-Keystone Health System
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Stereotactic body radiation therapy (SBRT) has been employed in the treatment of prostate cancer. Multiple single institution experiences suggest high biochemical control rates with acceptable toxicit...
Detailed Description
The optimal radiation schedule for the curative treatment of prostate cancer remains unknown. Prostate cancer patients receiving radiation therapy are typically treated 5 days per week for 8-9 weeks. ...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate diagnosed within 360 days of enrollment.
- Prostate Specific Antigen (PSA) documented within 90 days prior to registration.
- Clinical staging completed within 90 days of registration.
- No Nodal or Distant Metastases documented on CT or MRI of the pelvis and bone scan.
- Unfavorable Risk Prostate Carcinoma as Described is documented.
- No prior pelvic radiotherapy.
- No prior Trans-urethral resection of the prostate (TURP).
- Prostate volume \< 100 cc
- American Urologic Association (AUA) score \< 20
- No recent (within 5 years) or concurrent cancers other than non-melanoma skin cancers.
- Patient must have no medical or psychiatric illnesses that would interfere with treatment or follow-up.
- No implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and treatment delivery is allowed.
- Candidate for rectal spacer placement
Exclusion
- Other cancer diagnosis other than non-melanoma skin cancer with 5 years
- Prostate size greater than 100cc
- AUA greater than 20
- Implanted hardware impacting imaging
- Metastatic prostate cancer
- Contraindication to hormone therapy
Key Trial Info
Start Date :
July 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 12 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03822494
Start Date
July 12 2018
End Date
July 12 2028
Last Update
February 21 2025
Active Locations (1)
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1
Philadelphia CyberKnife
Philadelphia, Pennsylvania, United States, 19083