Prostate CancerCK-DESPOTNCT03822494
CyberKnife Dose Escalation Prostate Cancer Trial
A study testing CyberKnife SBRT in people with Prostate Cancer and Prostate Adenocarcinoma, run by Crozer-Keystone Health System at 1 site in United States.
Trial 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 toxicity in low risk prostate cancer but efficacy data in unfavorable type prostate cancer is less convincing. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
- What is being tested?
- CyberKnife SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to 12 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia CyberKnife
Philadelphia, Pennsylvania, 19083
About this study
Official title: CyberKnife Dose Escalation for Unfavorable and High-risk Prostate Cancer
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 toxicity in low risk prostate cancer but efficacy data in unfavorable type prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate radiation dose delivery to the prostate while sparing normal tissue.
Read the 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. Recent data suggest that large radiation fraction sizes are radio-biologically favorable over lower fraction sizes in prostate cancer radiotherapy. The sensitivity of a tumor or normal tissue to fraction size of radiation can be approximated by the alpha-beta ratio. It has been suggested that the alpha/beta ratio for prostate cancer is actually as low as 1.5 implying that the current radiation therapy paradigm for prostate cancer treatment might be fundamentally flawed, as high fraction sizes would be expected to damage tumor more readily.
Typical prostate SBRT doses do not appear to have similar efficacy in higher risk prostate cancer suggesting even higher doses are required. Many techniques including dose escalated external beam radiation therapy (EBRT), proton therapy (PT) and brachytherapy have been employed to increase dose to the prostate. Data from the ASCEND-RT trial utilizing low dose rate brachytherapy boost showed a dramatic 21% improvement in biochemical control at 9 years favoring brachytherapy boost compared to conventional dose escalated EBRT radiation therapy. However, no corresponding benefit was identified in overall survival, incidence of bone metastases or prostate cancer specific mortality while a 3 fold increase in late urinary toxicity was noted.
SBRT is well tolerated with minimal acute and late side effects. In this protocol, CK-SBRT will be used to target the microscopic and gross disease in the prostate, seminal vesicles. An escalated dose of 40 Gy in 5 fractions will be delivered to the entire target volume while any nodules visible within the prostate gland on endorectal MRI will receive 50 Gy in 5 fractions.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
- Being tested
- CyberKnife SBRT
- Keywords
- radiation therapy, Cyberknife, SBRT, Protons
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnife SBRTRadiation
Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalated CyberKnife SBRT | Experimental | DE-SBRT will be delivered using the CyberKnife robotic radiosurgery system. Patients will be treated with five SBRT treatments (8 Gy per fraction to the PTV, and 9-10 Gy per fraction to any nodules identified on endorectal MRI) over 7-10 days. Receives: Radiation: CyberKnife SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0
Genitourinary or Bowel Toxicity as a result of radiation therapy will be reported using
Measured: 24 Months
Secondary outcomes (6)
Biochemical Disease Free Survival
Time in months from completion of SBRT to biochemical failure
Measured: 24 Months
Duration of local control
time in months from SBRT completion to local failure
Measured: 24 Months
Distant Failure
time in months from SBRT completion to distant failure
Measured: 24 Months
Disease Free Survival
time in months from the date that the patient is determined to be free of disease to the date of known disease recurrence for any measure of disease.
Measured: 24 Months
Disease Specific Survival
time in months from completion of SBRT to death due to prostate cancer, other causes with active malignancy, or complications from treatment.
Measured: 24 Months
Overall Survival
ime in months from SBRT completion until death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start12 Jul 2018
- Primary completion21 Jun 2023
- Study completion12 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crozer-Keystone Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachelle Lanciano M.D., Crozer-Keystone Health System
- Investigators
- Rachelle Lanciano, MD, Study chair, Philadelphia CyberKnife -Crozer HealthRachelle Lanciano, MD, Principal investigator, Philadelphia CyberKnife -Crozer Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822494
- Sponsor's protocol ID
- PCK-02
- Acronym
- CK-DESPOT
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2019
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CyberKnife Dose Escalation for Unfavorable and High-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT03822494
- Acronym / sponsor ID
- CK-DESPOT / PCK-02
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
- Keywords
- radiation therapy, Cyberknife, SBRT, Protons
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Crozer-Keystone Health SystemUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 12 Jul 2028 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 toxicity in low risk prostate cancer but efficacy data in unfavorable type prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate radiation dose delivery to the prostate while sparing normal tissue.
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. Recent data suggest that large radiation fraction sizes are radio-biologically favorable over lower fraction sizes in prostate cancer radiotherapy. The sensitivity of a tumor or normal tissue to fraction size of radiation can be approximated by the alpha-beta ratio. It has been suggested that the alpha/beta ratio for prostate cancer is actually as low as 1.5 implying that the current radiation therapy paradigm for prostate cancer treatment might be fundamentally flawed, as high fraction sizes would be expected to damage tumor more readily.
Typical prostate SBRT doses do not appear to have similar efficacy in higher risk prostate cancer suggesting even higher doses are required. Many techniques including dose escalated external beam radiation therapy (EBRT), proton therapy (PT) and brachytherapy have been employed to increase dose to the prostate. Data from the ASCEND-RT trial utilizing low dose rate brachytherapy boost showed a dramatic 21% improvement in biochemical control at 9 years favoring brachytherapy boost compared to conventional dose escalated EBRT radiation therapy. However, no corresponding benefit was identified in overall survival, incidence of bone metastases or prostate cancer specific mortality while a 3 fold increase in late urinary toxicity was noted.
SBRT is well tolerated with minimal acute and late side effects. In this protocol, CK-SBRT will be used to target the microscopic and gross disease in the prostate, seminal vesicles. An escalated dose of 40 Gy in 5 fractions will be delivered to the entire target volume while any nodules visible within the prostate gland on endorectal MRI will receive 50 Gy in 5 fractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalated CyberKnife SBRT | Experimental | Radiation: CyberKnife SBRTDE-SBRT will be delivered using the CyberKnife robotic radiosurgery system. Patients will be treated with five SBRT treatments (8 Gy per fraction to the PTV, and 9-10 Gy per fraction to any nodules identified on endorectal MRI) over 7-10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyberKnife SBRTRadiation Therapy | Radiation | Dose Escalated CyberKnife SBRT |
Primary outcome
Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0
Time frame: 24 Months
Genitourinary or Bowel Toxicity as a result of radiation therapy will be reported using
6 secondary outcomes
Biochemical Disease Free Survival
Time frame: 24 Months
Duration of local control
Time frame: 24 Months
Distant Failure
Time frame: 24 Months
Disease Free Survival
Time frame: 24 Months
Disease Specific Survival
Time frame: 24 Months
Overall Survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachelle Lanciano, MD study chair
Philadelphia CyberKnife -Crozer Health
Rachelle Lanciano, MD principal investigator
Philadelphia CyberKnife -Crozer Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife SBRT in people with Prostate Cancer and Prostate Adenocarcinoma, run by Crozer-Keystone Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0 (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.