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Prostate CancerNCT00288106

S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT

An observational study of Prostate Cancer, run by SWOG Cancer Research Network at 52 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Learning about the long-term effects of chemoprevention drugs, such as finasteride, in patients with prostate cancer may help doctors plan better treatment and follow-up care. Read more about this study

Who is it for?
Ages 55 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Follow-up
How many people
961 participants
Where
52 sitesUnited States
Study dates
Sep 2005to May 2009
Phase
Observational
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 55 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Men diagnosed with prostate cancer on or before 12/31/03 after participation in the Prostate Cancer Prevention Trial (SWOG-9217)

Who may be able to join

  • Randomized on PCPT
  • Diagnosed with prostate cancer on or before December 31, 2003
  • DISEASE CHARACTERISTICS:
  • Diagnosed by either study site or central pathology review
  • PATIENT CHARACTERISTICS:
  • See inclusion criteria
  • PRIOR CONCURRENT THERAPY:
  • Not Applicable

Who cannot join

None listed.

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Oregon Health and Science University Cancer Institute

    Portland, Oregon, 97239-3098

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer

RATIONALE: Learning about the long-term effects of chemoprevention drugs, such as finasteride, in patients with prostate cancer may help doctors plan better treatment and follow-up care.

PURPOSE: This clinical trial is following patients who were diagnosed with prostate cancer while undergoing treatment with either finasteride or a placebo on the Prostate Cancer Prevention Trial (PCPT).

Read the detailed description

OBJECTIVES:

  • Compare the time to metastases in patients who were diagnosed with high grade or low grade prostate cancer on or before December 31, 2003 and were treated with finasteride or placebo while enrolled on the Prostate Cancer Prevention Trial (SWOG-9217).
  • Compare the difference in time to secondary therapy after definitive therapy with radiotherapy or radical prostatectomy in these patients.
  • Compare the difference in time to prostate-specific antigen recurrence after definitive therapy with radiotherapy or radical prostatectomy in these patients.
  • Compare the difference in all-cause and prostate cancer mortality in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to survival status (alive vs deceased).

Patients provide information about their general health, prostate cancer treatment history, prostate cancer status (i.e., disease progression and metastases data), and prostate-specific antigen (PSA) test results at baseline and then every 6 months for up to 8 years. Next of kin of deceased patients are asked to release the patients' medical records in order to obtain information about the patients' prostate cancer treatment history, prostate cancer progression and metastases, PSA test results, and cause of death.

PROJECTED ACCRUAL: A minimum of 75% of the 2,401 patients (n=1800) diagnosed with prostate cancer on PCPT are needed to have minimal power to evaluate the objectives.

Conditions
Prostate Cancer
Being tested
Follow-up
Keywords
recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follow-upOther

    Also called Observation

    No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT

Study groups in NCT00288106
Study groupRoleWhat they receive
Long Term Follow-UpFollow-up data collection study for men who developed prostate cancer after participation in SWOG-9217 (PCPT)
Receives: Other: Follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to metastases

    Measured: Up to 8 years post registration

Secondary outcomes (3)

  1. Time to secondary therapy after definitive therapy

    Definitive therapy is defined as radiotherapy or radical prostatectomy.

    Measured: Up to 8 years post registration

  2. Time to PSA recurrence after definitive therapy

    Definitive therapy is defined as radiotherapy or radical prostatectomy.

    Measured: Up to 8 years post registration

  3. All cause and prostate cancer-specific mortality

    Measured in a time-to-event analysis

    Measured: Up to 8 years post registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2006 (estimated)
  2. Study startSep 2005
  3. Primary completionMay 2009
  4. Study completionMay 2009

Why it stopped: Poor accrual resulted in lack of feasibility to evaluate endpoints.

Resources

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
Cohort
Time perspective
Prospective
Enrolment
961 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00288106
Sponsor's protocol ID
CDR0000466341
Other IDs
U10CA012027, S0437
Status last verified
Sep 2015
First submitted
6 Feb 2006
Last updated
30 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Chau CH, Price DK, Till C, Goodman PJ, Chen X, Leach RJ, Johnson-Pais TL, Hsing AW, Hoque A, Tangen CM, Chu L, Parnes HL, Schenk JM, Reichardt JK, Thompson IM, Figg WD. Finasteride concentrations and prostate cancer risk: results from the Prostate Cancer Prevention Trial. PLoS One. 2015 May 8;10(5):e0126672. doi: 10.1371/journal.pone.0126672. eCollection 2015.

    PubMed 25955319

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by SWOG Cancer Research Network at 52 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 8 inclusion and 0 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: stopped early, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 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.

Are results available for this study?

The study was stopped early (reason given: Poor accrual resulted in lack of feasibility to evaluate endpoints.). Results are not available in the source record.

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?

Time to metastases (time frame: Up to 8 years post registration). 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 NCT00288106, 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 30 Sep 2015.

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