Adenocarcinoma of the ProstatePhase 1CCRO025NCT02064036
Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate
A Phase 1 study testing Stereotactic Radiosurgical Boost, Casodex and Leuprolide in people with Adenocarcinoma of the Prostate, run by University of California, Davis at 1 site in United States.
Trial summary
We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men with unfavorable intermediate and high risk localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Stereotactic Radiosurgical Boost, Casodex and Leuprolide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2013to 29 Oct 2021
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence
- History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
- Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MRI), (but not by nodal sampling, or dissection) within 90 days prior to registration.
- Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm.
- No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.
- Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
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- Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration.
- Study entry PSA should not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.
- Zubrod Performance Status 0-2
- Complete blood count (CBC)/differential obtained within 2 weeks (14 days) prior to registration on study, with adequate bone marrow function
- Patient must be able to provide study specific informed consent prior to study entry.
Who cannot join
- Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years.
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Previous hormonal therapy
- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤ 60 days prior to the date of registration.
- Use of finasteride within 30 days prior to registration
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- Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
- Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable. See Section 3.2.1.
- Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity including heart issues, infection and liver problems
- Patients who are sexually active and not willing/able to use medically acceptable forms of contraception
- Prior allergic reaction to the hormones involved in this protocol
- Patients status-post a negative lymph node dissection are not eligible
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Sacramento Cancer Center Dept of Radiation Oncology
Sacramento, California, 95817
About this study
Official title: Whole-Pelvic Radiotherapy With a Stereotactic Body Radiotherapy Boost and Long-Term Androgen Deprivation for Unfavorable-Intermediate and High Risk Localized Adenocarcinoma of the Prostate.
We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men with unfavorable intermediate and high risk localized prostate cancer.
Our primary objective is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.
Read the detailed description
The primary objective of this study is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.
The secondary objective is to assess biochemical control at 24 months following the experimental treatment strategy by the "Phoenix definition". Patients not meeting these prostate-specific antigen (PSA) criteria (Phoenix Definition) for failure who undergo salvage therapies (such as androgen deprivation therapy (ADT), radical prostatectomy or brachytherapy, or Cryosurgery) should also be declared as failures at the time a positive biopsy is obtained or salvage therapy is administered, whichever comes first.
Another secondary objective is to assess toxicity of the experimental treatment approach as scored by the Common Terminology Criteria for Adverse Events The third secondary objective is to assess prostate organ motion during hypofractionated radiotherapy. To assess motion of the prostate during the protracted delivery of hypofractionated radiotherapy as assessed by implanted electromagnetic transponder beacons.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Stereotactic Radiosurgical Boost, Casodex, Leuprolide
- Keywords
- Prostate Cancer, Radiotherapy, Androgen Deprivation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Radiosurgical BoostRadiation
Also called Intensity Modulated Radiotherapy (IMRT), Radiotherapy,, X-ray therapy, Irradiation
Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade to Whole Pelvis, Prostate, and Seminal Vesicles Followed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance
CasodexDrug
Also called Bicalutamide
Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy
LeuprolideDrug
Also called Goserelin
Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Neoadjuvant Androgen Blockade (Casodex) Followed by: Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade (Casodex and Leuprolide) to Whole Pelvis, Prostate, and Seminal VesiclesFollowed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance Followed by: Adjuvant Androgen Blockade (Casodex) Receives: Radiation: Stereotactic Radiosurgical Boost; Drug: Casodex; Drug: Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Assessment
Tumors will be assessed using the American Joint Committee on Cancer (AJCC) Staging System, 7th Edition. This system consists of the following subscales: the extent of the primary tumor (T category), whether the cancer has spread to nearby lymph nodes (N category), the absence or presence of distant metastasis (M category), the PSA level at the time of diagnosis, and the Gleason score, based on the prostate biopsy (or surgery).
Measured: 24 months
Secondary outcomes (1)
Zubrod Performance Scale
This is a scale used to evaluate the patient's performance status is an attempt to quantify cancer patients' general well-being and activities of daily life.
Measured: Weekly during radiation treatment; every three months during hormone therapy; every six months for 3 yrs after hormone therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study start6 Jun 2013
- Primary completion3 Dec 2020
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Valicenti, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064036
- Sponsor's protocol ID
- 421870
- Other IDs
- CCRO025
- Acronym
- CCRO025
- Status last verified
- Oct 2022
- First submitted
- 22 Jan 2014
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Pelvic Radiotherapy With a Stereotactic Body Radiotherapy Boost and Long-Term Androgen Deprivation for Unfavorable-Intermediate and High Risk Localized Adenocarcinoma of the Prostate.
- ClinicalTrials.gov ID
- NCT02064036
- Acronym / sponsor ID
- CCRO025 / 421870
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- Prostate Cancer, Radiotherapy, Androgen Deprivation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 6 Jun 2013 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 17 Feb 2014 (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.
We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men with unfavorable intermediate and high risk localized prostate cancer.
Our primary objective is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.
Detailed description
The primary objective of this study is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.
The secondary objective is to assess biochemical control at 24 months following the experimental treatment strategy by the "Phoenix definition". Patients not meeting these prostate-specific antigen (PSA) criteria (Phoenix Definition) for failure who undergo salvage therapies (such as androgen deprivation therapy (ADT), radical prostatectomy or brachytherapy, or Cryosurgery) should also be declared as failures at the time a positive biopsy is obtained or salvage therapy is administered, whichever comes first.
Another secondary objective is to assess toxicity of the experimental treatment approach as scored by the Common Terminology Criteria for Adverse Events The third secondary objective is to assess prostate organ motion during hypofractionated radiotherapy. To assess motion of the prostate during the protracted delivery of hypofractionated radiotherapy as assessed by implanted electromagnetic transponder beacons.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Radiation: Stereotactic Radiosurgical Boost, Drug: Casodex, Drug: LeuprolideNeoadjuvant Androgen Blockade (Casodex) Followed by: Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade (Casodex and Leuprolide) to Whole Pelvis, Prostate, and Seminal VesiclesFollowed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance Followed by: Adjuvant Androgen Blockade (Casodex) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence
- History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
- Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MRI), (but not by nodal sampling, or dissection) within 90 days prior to registration.
- Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm.
- No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.
Key exclusion criteria (13 listed)
- Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years.
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Previous hormonal therapy
- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤ 60 days prior to the date of registration.
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 |
|---|---|---|
| Stereotactic Radiosurgical BoostAlso: Intensity Modulated Radiotherapy (IMRT), Radiotherapy,, X-ray therapy, IrradiationIntensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade to Whole Pelvis, Prostate, and Seminal Vesicles Followed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance | Radiation | Single |
| CasodexAlso: BicalutamideNeoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy | Drug | Single |
| LeuprolideAlso: GoserelinNeoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy | Drug | Single |
Primary outcome
Tumor Assessment
Time frame: 24 months
Tumors will be assessed using the American Joint Committee on Cancer (AJCC) Staging System, 7th Edition. This system consists of the following subscales: the extent of the primary tumor (T category), whether the cancer has spread to nearby lymph nodes (N category), the absence or presence of distant metastasis (M category), the PSA level at the time of diagnosis, and the Gleason score, based on the prostate biopsy (or surgery).
1 secondary outcome
Zubrod Performance Scale
Time frame: Weekly during radiation treatment; every three months during hormone therapy; every six months for 3 yrs after hormone therapy
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 18 Oct 2022.
- 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.
Richard Valicenti, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Radiosurgical Boost, Casodex and Leuprolide in people with Adenocarcinoma of the Prostate, run by University of California, Davis 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 11 inclusion and 13 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 18 Oct 2022. 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.
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?
Tumor Assessment (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 18 Oct 2022.