Can Pre-Surgery hormone cocktail boost erection recovery in prostate cancer?
NCT ID NCT02949284
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 Hide 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for High-risk prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a shorter hormone therapy course be just as effective for High-Risk prostate cancer?
- Man's best friend as cancer detector: can dogs sniff out prostate cancer?
- Can a single radiation type spare prostate cancer patients from extra side effects?
- New scan could reveal hidden cancer in High-Risk prostate patients
- Promising prostate cancer combo trial pulled before starting
- New scan could revolutionize prostate cancer monitoring