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Can Pre-Surgery hormone cocktail boost erection recovery in prostate cancer?

NCT ID NCT02949284

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 11, 2026 · Updated 5 times

Summary

This phase 2 trial tests whether giving hormone therapy before prostate surgery helps men with high-risk prostate cancer recover erectile function better. About 90 men will receive either apalutamide alone or a combination of apalutamide, abiraterone, GnRH agonist, and prednisone before nerve-sparing prostate removal. The goal is to see if these drugs shrink tumors and improve post-surgery potency compared to surgery alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apalutamide, abiraterone acetate, GnRH agonist, prednisone
What this could lead to
If successful, this approach could help men with high-risk prostate cancer recover erectile function better after surgery, potentially improving quality of life.
What could go wrong
This is a small, early-phase trial (90 participants) testing combinations of drugs before surgery. Results may not apply to all patients, and side effects from hormone therapy can be significant.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2017

Expected to finish

Jun 2027

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Histologically proven adenocarcinoma of the prostate and: Gleason \> 8 OR prostatic specific antigen (PSA) \> 20 and more than 1 positive core * Patients with Eastern Cooperative Oncology Group performance scale (ECOG PS) 0 or 1 * Clinical stage T3 or less as demonstrated by abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) will be selected as the prostate is resectable * Hemoglobin \>= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization * Platelet count \>= 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization * Serum albumin \>= 3.0 g/dL * Glomerular filtration rate (GFR) \>= 45 mL/min * Serum potassium \>= 3.5 mmol/L * Serum total bilirubin =\< 1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 × ULN, subject may be eligible) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 × ULN * Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry * Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug Exclusion Criteria: * Clinical stage T4 (invasion into rectum or ureters) significantly increases the morbidity of the surgery * Patients with rectal or ureteral invasion will be considered to have unresectable disease * History of any of the following: * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy) * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial within 6 months prior to randomization * Venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks) within 6 months prior to randomization * Clinically significant ventricular arrhythmias within 6 months prior to randomization * Metastatic prostate cancer * Baseline moderate or severe hepatic impairment (Child-Pugh class B or C)

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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

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06519, United States

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