Prostate CancerASCaPNCT00949819
Active Surveillance for Cancer of the Prostate (ASCaP)
An observational study of Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer. Read more about this study
- Who is it for?
- Ages 30 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Active surveillance
- How many people
- 462 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2009to Dec 2028
- Phase
- Observational
- 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 30 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate.
- Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
- No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
- Patient has elected Active Surveillance as preferred management plan for prostate cancer.
- Patient consent has been obtained according to local Institutional Review Board .
- Patient is accessible and compliant for follow-up.
Who cannot join
- Unwillingness or inability to undergo serial prostate biopsy.
- Overall life expectancy less than 2 years
- Advanced prostate cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Leonard S Marks, M.D.
About this study
Official title: The UCLA ASCAP Project is an Observational, Longitudinal, and Open-ended Study Aimed at Establishing a Structured Program of Non-interventional Follow-up for Localized Prostate Cancer.
Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer.
Read the detailed description
This protocol is not designed as a formal clinical trial, but rather an observational protocol; no treatments and no randomization are included. Longitudinally, specimens and clinical data will be collected to provide information on the following:
- Imaging studies of the prostate
- Rates of curative intervention
- Measures of tumor recurrence/progression
- Disease specific survival
- Overall survival
- Clinical data to track Quality of Life
- Conditions
- Prostate Cancer
- Being tested
- Active surveillance
- Keywords
- Prostate Cancer, Low risk, Gleason 6, Active surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceOther
Serial, long term data collection and active surveillance
| Study group | Role | What they receive |
|---|---|---|
| no treatment | Men with previously untreated, early stage prostate cancer. Receives: Other: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.
Measured: Interim data analysis will be made every year
Secondary outcomes (1)
Determine the clinical predictors of disease progression. Measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer. Determine factors that lead to active intervention
Measured: Interim data analysis will be done each year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study start4 Jul 2009
- Primary completion5 Jul 2027 (estimated)
- Study completionDec 2028 (estimated)
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 Jonsson Comprehensive Cancer CenterThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonard S Marks, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949819
- Sponsor's protocol ID
- 11-002281
- Acronym
- ASCaP
- Status last verified
- May 2026
- First submitted
- 29 Jul 2009
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Martin SC, Gonzalez S, Kwan L, Delfin M, Nguyen AV, Brisbane W, Felker E, Sisk A, Priester A, Natarajan S, Marks LS. Evolution of Active Surveillance of Prostate Cancer: Impact of Magnetic Resonance Imaging, Magnetic Resonance Imaging-Guided Biopsy, and Focal Therapy. J Urol. 2025 Aug;214(2):177-187. doi: 10.1097/JU.0000000000004559. Epub 2025 Apr 21.
PubMed 40257918
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UCLA ASCAP Project is an Observational, Longitudinal, and Open-ended Study Aimed at Establishing a Structured Program of Non-interventional Follow-up for Localized Prostate Cancer.
- ClinicalTrials.gov ID
- NCT00949819
- Acronym / sponsor ID
- ASCaP / 11-002281
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Low risk, Gleason 6, Active surveillance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 462 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 4 Jul 2009 (actual)
- Primary completion
- 5 Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Jul 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.
Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer.
Detailed description
This protocol is not designed as a formal clinical trial, but rather an observational protocol; no treatments and no randomization are included. Longitudinally, specimens and clinical data will be collected to provide information on the following:
- Imaging studies of the prostate
- Rates of curative intervention
- Measures of tumor recurrence/progression
- Disease specific survival
- Overall survival
- Clinical data to track Quality of Life
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | Other: Active surveillanceMen with previously untreated, early stage prostate cancer. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (6 listed)
- Histologically confirmed adenocarcinoma of the prostate.
- Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
- No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
- Patient has elected Active Surveillance as preferred management plan for prostate cancer.
- Patient consent has been obtained according to local Institutional Review Board .
Key exclusion criteria (3 listed)
- Unwillingness or inability to undergo serial prostate biopsy.
- Overall life expectancy less than 2 years
- Advanced 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 |
|---|---|---|
| Active surveillanceSerial, long term data collection and active surveillance | Other | no treatment |
Primary outcome
Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.
Time frame: Interim data analysis will be made every year
1 secondary outcome
Determine the clinical predictors of disease progression. Measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer. Determine factors that lead to active intervention
Time frame: Interim data analysis will be done each year
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 26 May 2026.
- Derived from this study: PubMed 40257918Martin SC, Gonzalez S, Kwan L, Delfin M, Nguyen AV, Brisbane W, Felker E, Sisk A, Priester A, Natarajan S, Marks LS. Evolution of Active Surveillance of Prostate Cancer: Impact of Magnetic Resonance Imaging, Magnetic Resonance Imaging-Guided Biopsy, and Focal Therapy. J Urol. 2025 Aug;214(2):177-187. doi: 10.1097/JU.0000000000004559. Epub 2025 Apr 21.
- 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.
Leonard S Marks, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Jonsson Comprehensive Cancer Center 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 May 2026. 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?
Contact Malu Macairan ((310) 794-3566, mmacairan@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables. (time frame: Interim data analysis will be made every year). 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 NCT00949819, 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 26 May 2026.