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Triple therapy shows promise for aggressive prostate cancer

NCT ID NCT02023463

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a combination of enzalutamide (a hormone-blocking drug), radiation therapy, and standard hormone therapy in 25 men with intermediate or high-risk prostate cancer. The main goal was to check for side effects and find the best way to give the treatment. Researchers also tracked PSA levels and quality of life. The approach aims to control the disease, not cure it, as ongoing hormone therapy is typically needed.

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

25 people

The number who actually took part.

Started

Apr 2014

Expected to finish

Jan 2040

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. Prostate adenocarcinoma without distant metastatic disease with either Gleason score ≥ 7, PSA ≥ 10 ng/ml, or T2b or greater disease 2. Age \> 18 3. Performance Status: ECOG 0-1 4. Hematologic (minimal values): * Absolute neutrophil count \> 1,500/mm3 * Hemoglobin \> 8.0 g/dl * Platelet count \> 100,000/mm3 5. Hepatic function * Total bilirubin \< Upper limit of normal (ULN)(except for Gilbert's disease) * AST (SGOT) \< 1.5 x ULN * ALT (SGPT) \< 1.5 x ULN 6. Creatinine \< 1.5 x ULN 7. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. Exclusion Criteria: 1. Patients with a history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation or the use of concomitant medications that may lower the seizure threshold 2. History of urological surgery or procedures predisposing to GU complications after radiation (will be determined by radiation oncologist) 3. History of diverticulitis, rectal bleeding or other lower GI diseases predisposing to GI complications after radiation (will be determined by radiation oncologist) 4. History of prior chemotherapy or pelvic irradiation, 5. History of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin. 6. Documented distant metastatic disease. NOTE: pelvic lymphadenopathy is NOT excluded. 7. Prior radical prostatectomy or cryosurgery for prostate cancer or bilateral orchiectomy. 8. No experimental medications within 30 days of study entry 9. Patients currently taking the following medications: * CYP2C8 inhibitors (e.g. Gemfibrozil) * CYP2C8 inducers (e.g. rifampin) * CYP3A4 inhibitors (itraconazole) * CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

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