Prostate CancerPhase 1NCT01041326
Preoperative Radiation Therapy for High Risk Prostate Cancer
A Phase 1 study testing Radiation and Radical Prostatectomy in people with Prostate Cancer, run by Duke University at 2 sites in United States.
Trial summary
This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease. Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiation and Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2005to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have
- biopsy-confirmed "high-risk" prostate cancer, defined as A. PSA > 20, B. Gleason Score (GS) >/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or clinical stage = T2b / T2c.
- a negative bone scan,
- be medically fit to undergo surgery as determined by treating urologist,
- age > 18,
- KPS must be >/= 80,
Show all 9Show fewer
- no prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
- no prior invasive malignancy, except non- melanomatous skin cancer unless disease free for a minimum of 5 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
- Subjects must freely sign informed consent to enroll in the study.
Who cannot join
- prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
- prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 5 years.
- Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or chest x-ray.
- Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
- History of prior pelvic radiation therapy.
- History of androgen deprivation therapy or chemotherapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High Risk, Localized Carcinoma of the Prostate
This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease. Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone. Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy, respectively. The patient will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
- Conditions
- Prostate Cancer
- Being tested
- Radiation, Radical Prostatectomy
- Keywords
- prostatectomy, radiation, neoadjuvant
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes
Radical ProstatectomyProcedure or surgery
Patients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy. If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy. This surgical procedure will be performed by one of the standard accepted approaches.
| Study group | Role | What they receive |
|---|---|---|
| Leve 1 Radiation | Experimental | Subjects in Group 1 will receive 39.6 Gy (at 1.8 Gy/fx) to the whole pelvis. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation. Receives: Radiation: Radiation; Procedure: Radical Prostatectomy |
| Level 2 Radiation | Experimental | Subjects in Group 2 will receive 45 Gy (at 1.8 Gy/fx) to the whole pelvis. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation. Receives: Radiation: Radiation; Procedure: Radical Prostatectomy |
| Level 3 Radiation | Experimental | Subjects in Group 3 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 Gy. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation. Receives: Radiation: Radiation; Procedure: Radical Prostatectomy |
| Level 4 Radiation | Experimental | Subjects in Group 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 54 Gy. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation. Receives: Radiation: Radiation; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative morbidity
Measured: 30 day
Secondary outcomes (3)
continence
Measured: 1 year
erectile function
Measured: 1 year
biochemical recurrence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startApr 2005
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Bridget F Koontz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041326
- Sponsor's protocol ID
- Pro00006510
- Status last verified
- Jul 2013
- First submitted
- 30 Dec 2009
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koontz BF, Quaranta BP, Pura JA, Lee WR, Vujaskovic Z, Gerber L, Haake M, Anscher MS, Robertson CN, Polascik TJ, Moul JW. Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):88-93. doi: 10.1016/j.ijrobp.2013.05.014. Epub 2013 Jun 19.
PubMed 23790772
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High Risk, Localized Carcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT01041326
- Acronym / sponsor ID
- Pro00006510
- Conditions
- Prostate Cancer
- Keywords
- prostatectomy, radiation, neoadjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University
- Study start
- Apr 2005
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 31 Dec 2009 (estimated)
- 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.
This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease. Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone. Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy, respectively. The patient will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Leve 1 Radiation | Experimental | Radiation: Radiation, Procedure: Radical ProstatectomySubjects in Group 1 will receive 39.6 Gy (at 1.8 Gy/fx) to the whole pelvis. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation. |
| Level 2 Radiation | Experimental | Radiation: Radiation, Procedure: Radical ProstatectomySubjects in Group 2 will receive 45 Gy (at 1.8 Gy/fx) to the whole pelvis. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation. |
| Level 3 Radiation | Experimental | Radiation: Radiation, Procedure: Radical ProstatectomySubjects in Group 3 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 Gy. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation. |
| Level 4 Radiation | Experimental | Radiation: Radiation, Procedure: Radical ProstatectomySubjects in Group 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 54 Gy. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must have
- biopsy-confirmed "high-risk" prostate cancer, defined as A. PSA > 20, B. Gleason Score (GS) >/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or clinical stage = T2b / T2c.
- a negative bone scan,
- be medically fit to undergo surgery as determined by treating urologist,
- age > 18,
Key exclusion criteria (7 listed)
- prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
- prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 5 years.
- Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or chest x-ray.
- Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
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 |
|---|---|---|
| RadiationPre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes | Radiation | Leve 1 Radiation, Level 2 Radiation, Level 3 Radiation, Level 4 Radiation |
| Radical ProstatectomyPatients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy. If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy. This surgical procedure will be performed by one of the standard accepted approaches. | Procedure or surgery | Leve 1 Radiation, Level 2 Radiation, Level 3 Radiation, Level 4 Radiation |
Primary outcome
post-operative morbidity
Time frame: 30 day
3 secondary outcomes
continence
Time frame: 1 year
erectile function
Time frame: 1 year
biochemical recurrence
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
- Results publication: PubMed 23790772Koontz BF, Quaranta BP, Pura JA, Lee WR, Vujaskovic Z, Gerber L, Haake M, Anscher MS, Robertson CN, Polascik TJ, Moul JW. Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):88-93. doi: 10.1016/j.ijrobp.2013.05.014. Epub 2013 Jun 19.
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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.
Bridget F Koontz, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiation and Radical Prostatectomy in people with Prostate Cancer, run by Duke University at 2 sites 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
post-operative morbidity (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01041326, which also lists 1 linked publication.
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 17 Jul 2013.