New combo therapy aims to delay return of spread prostate cancer
NCT ID NCT00544830
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding targeted radiation to standard hormone therapy can better control prostate cancer that has spread to a few spots in the body. About 29 men with hormone-sensitive prostate cancer and up to 5 metastases will receive hormone therapy (bicalutamide, goserelin, or leuprolide) plus intensity-modulated radiation therapy. The main goal is to see how long it takes for PSA levels to rise again, which would signal the cancer is returning.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hormone therapy (bicalutamide, goserelin, or leuprolide) and intensity-modulated radiation therapy
- What this could lead to
- If successful, this approach could help control prostate cancer that has spread to a few places, potentially delaying the need for more aggressive treatment.
- What could go wrong
- This is a small, early-phase trial with only 29 participants, so results may not apply to everyone. Hormone therapy can cause side effects like hot flashes and fatigue.
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
-
29 people
The number who actually took part.
- Started
-
Jul 2006
- Expected to finish
-
Feb 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
-
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 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: * Patients with histologically proven diagnosis of adenocarcinoma of the prostate stage N1, N2, N3, M1a, M1b, M1c with =\< 5 metastatic lesions; if the diagnosis of metastasis in the lymph node is based solely on imaging computed tomography (CT) scan or magnetic resonance imaging (MRI), the longitudinal diameter of the lymph node has to be \>= 2.0 cm; if the lymph node is positive on positron emission tomography (PET) or ProstaScint scan, the longitudinal diameter of the lymph node on CT scan or MRI has to be \>= 1.5 cm * Patients who have measurable disease must have had X-rays, scans or physical examination used for tumor measurement completed within 28 days prior to registration; patients must have non-measurable disease assessed within 42 days prior to registration * Patients must have had documented PSA of \> 2 prior to onset of androgen deprivation * Patients might have received up to 36 weeks of adjuvant androgen deprivation therapy and up to 36 weeks of androgen deprivation therapy for metastatic disease prior to enrollment to this study; patients may be on androgen deprivation for metastatic disease at the time of enrollment to the protocol; adjuvant therapy must have been completed at least 2 years before androgen deprivation for metastatic disease and patients must remain hormone sensitive * Prior radiation therapy for metastatic disease is not allowed * Prior chemotherapy for metastatic disease is not allowed; prior neoadjuvant and adjuvant chemotherapy is allowed; patients must have recovered from all acute side-effects related to previous systemic therapy * Patients are allowed to receive one prior systemic non-chemotherapeutic treatment (i. e. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, differentiation agent) for recurrent or metastatic disease; patients must have recovered from all acute side-effects related to previous systemic therapy * Use of bisphosphonates is allowed at the discretion of treating physician * Patients must be capable of understanding the nature of the trial and must give written informed consent * Patients must have a World Health Organization (WHO) performance status of 0, 1, or 2 Exclusion Criteria: * Patients with unstable or severe intercurrent medical conditions or active, uncontrolled infection * Patients with a history of orchiectomy * Patients undergoing therapy with other investigational agents; patients must have recovered from all acute effects of previously administered investigational agents and sufficient time must have elapsed since last administration to ensure the drug interactions not occur during this study * Patients with a history of brain metastases or who currently have treated or untreated brain metastases * Patients who have demonstrated refractoriness to hormone therapy with luteinizing hormone-releasing hormone (LHRH) agonist; refractoriness is defined as occurrence of one of the following while on therapy with LHRH agonist: increase in PSA by 25% over baseline (to at least \> 2 ng/ml) on two consecutive PSA measurements, 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, clear worsening of any non-measurable disease, reappearance of any lesion that had disappeared, appearance of any new lesion
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for PSA level greater than two are added.
By submitting, you agree to our Terms of use
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
-
City of Hope Medical Center
Duarte, California, 91010, United States
-
City of Hope South Pasadena
South Pasadena, California, 91030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Chemo-Targeted drug combo outsmart Treatment-Resistant prostate cancer?
- New drug combo shows promise for tough prostate cancer
- New combo attack on hard-to-treat prostate cancer shows promise
- New drug combo tested to stop prostate cancer spread before surgery
- New hope for tough prostate cancer: drug cocktails under trial
- Can surgery boost survival in metastatic prostate cancer?