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Extended immunotherapy shows promise for tough prostate cancer

NCT ID NCT05806814

Disease control Sponsor: University of Oklahoma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing whether giving an extra dose of the immunotherapy drug Sipuleucel-T can strengthen the immune system's attack on prostate cancer that has spread and stopped responding to hormone therapy. Fifteen men with this advanced cancer will receive three infusions over about 14 weeks instead of the usual two. Researchers will measure immune responses and check if the extended schedule is practical and safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

15 people

The number who actually took part.

Started

Nov 2023

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men ≥ 18 years of age 2. Prostate cancer with history of metastasis 3. Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Life expectancy of ≥ 6 months Exclusion Criteria: 1. Previously received Sipuleucel-T (Provenge®) 2. Known malignancies other than prostate cancer likely to require treatment within 6 months following registration 3. A requirement for systemic immunosuppressive therapy (\>10mg Prednisone daily or equivalent) 4. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF 5. Any infection requiring antibiotic therapy within 1 week prior to registration

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration-resistant prostate cancer (MCRPC)

Contacts and locations

Locations

  • University of Oklahoma Health Sciences Center, Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.