PSA Level Greater Than TwoPhase 2NCT00544830

Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing Bicalutamide, Goserelin Acetate and Intensity-Modulated Radiation Therapy in people with PSA Level Greater Than Two and Stage IV Prostate Adenocarcinoma AJCC v7, run by City of Hope Medical Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
What is being tested?: Bicalutamide, Goserelin Acetate and Intensity-Modulated Radiation Therapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 2 sitesUnited States
Study dates: 7 Aug 2006to 15 Feb 2027
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

City of Hope Medical Center
Duarte, California, 91010
City of Hope South Pasadena
South Pasadena, California, 91030

Other trials in United States

About this study

Official title: Androgen Deprivation and Localized Radiotherapy to Metastases in Patients With Oligometastatic Hormone - Sensitive Prostate Cancer

This phase II trial studies how well hormone therapy and intensity-modulated radiation therapy work in treating patients with prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Anti-hormone therapy using goserelin, leuprolide acetate, or bicalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving hormone therapy and intensity-modulated radiation therapy may work better in treating patients with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

To evaluate the time to prostate-specific antigen (PSA) relapse in patients with oligometastatic (=< 5 lesions) hormone-sensitive prostate cancer treated with 36 weeks of androgen deprivation therapy and localized radiotherapy to all known tumor sites.

II. To assess the prostate-specific-antigen (PSA) and objective response rate to treatment with 36 weeks of androgen deprivation and localized radiotherapy in patients with oligometastatic hormone-sensitive prostate cancer.

III. To assess the toxicity of 36 weeks of androgen deprivation and localized radiation therapy to oligometastases in patients with oligometastatic hormone-sensitive prostate cancer.

IV. In appropriate situations evaluate the feasibility and toxicities of using helical tomotherapy image-guided intensity-modulated radiation therapy (IMRT) to treat oligometastatic sites.

OUTLINE:

ANDROGEN DEPRIVATION THERAPY (ADT): Patients not currently on ADT receive goserelin acetate subcutaneously (SC) or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide orally (PO) once daily (QD). Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.

RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.

After completion of study treatment, patients are followed up every 4 weeks for 2 years, then every 3 months after year 2, and then every 6 months thereafter.

Conditions: PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
Being tested: Bicalutamide, Goserelin Acetate, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Leuprolide Acetate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BicalutamideDrug
Also called Casodex, Cosudex, ICI 176,334, ICI 176334
Given PO
Goserelin AcetateDrug
Also called ZDX, Zoladex
Given SC
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy
Undergo IMRT
Laboratory Biomarker AnalysisOther
Correlative studies
Leuprolide AcetateDrug
Also called A-43818, Abbott 43818, Abbott-43818, Carcinil
Given via injection

Study groups in NCT00544830
Study group	Role	What they receive
Treatment (androgen therapy, radiation therapy)	Experimental	ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Receives: Drug: Bicalutamide; Drug: Goserelin Acetate; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Drug: Leuprolide Acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Prostate-specific Antigen (PSA) Relapse
Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to > 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is > 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is > 3.
Measured: End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower)

Secondary outcomes (6)

Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks.
Number of Patients who achieved PSA nadir of < 0.2 at 36 weeks.
Measured: During the time period between on-study PSA to off-study PSA, up to 36 weeks.
Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment).
Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment .
Measured: Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks.
Length of Follow-up
Length of follow-up in weeks to off-study date. Patients are treated for 36 weeks (+/- 2 weeks) with androgen deprivation therapy. Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 264.8 weeks (61.4 months; 5.1 years). Patients will remain off-treatment until they meet the criteria for re-treatment with androgen deprivation therapy, whereupon they will be taken off of the protocol. After patients are taken off protocol, we will do a chart review for long-term outcomes.
Measured: Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 61.4 months
Count of Patients Remaining Off of Therapy
Patients who remained off of therapy, in remission, out of the number of patients with metastases limited to pelvic lymph nodes.
Measured: after 36 week LHRH treatment window.
Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes.
Length of follow-up of the 8 patients with metastases limited to pelvic lymph nodes, months. Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.
Measured: Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.
CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes.
Number of patients remaining in complete remission without androgen deprivation therapy in patients with metastases limited to pelvic lymph nodes.
Measured: after 36 weeks of LHRH therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 200615 Feb 2027

First posted16 Oct 2007 (estimated)
Study start7 Aug 2006
Primary completion16 Mar 2011
Study completion15 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PSA Level Greater Than TwoStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00544830
Sponsor's protocol ID: 05190
Other IDs: NCI-2010-00425, 05190, P30CA033572
Status last verified: Oct 2026
First submitted: 13 Oct 2007
Last updated: 28 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Androgen Deprivation and Localized Radiotherapy to Metastases in Patients With Oligometastatic Hormone - Sensitive Prostate Cancer
ClinicalTrials.gov ID: NCT00544830
Acronym / sponsor ID: 05190
Conditions: PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 29 participants (actual)
Lead sponsor: City of Hope Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 7 Aug 2006 (actual)
Primary completion: 16 Mar 2011 (actual)
Study completion: 15 Feb 2027 (estimated)
First posted: 16 Oct 2007 (estimated)
Results: Posted 6 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To evaluate the time to prostate-specific antigen (PSA) relapse in patients with oligometastatic (=< 5 lesions) hormone-sensitive prostate cancer treated with 36 weeks of androgen deprivation therapy and localized radiotherapy to all known tumor sites.

III. To assess the toxicity of 36 weeks of androgen deprivation and localized radiation therapy to oligometastases in patients with oligometastatic hormone-sensitive prostate cancer.

IV. In appropriate situations evaluate the feasibility and toxicities of using helical tomotherapy image-guided intensity-modulated radiation therapy (IMRT) to treat oligometastatic sites.

OUTLINE:

After completion of study treatment, patients are followed up every 4 weeks for 2 years, then every 3 months after year 2, and then every 6 months thereafter.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (androgen therapy, radiation therapy)	Experimental	Drug: Bicalutamide, Drug: Goserelin Acetate, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Drug: Leuprolide AcetateADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BicalutamideAlso: Casodex, Cosudex, ICI 176,334, ICI 176334Given PO	Drug	Treatment (androgen therapy, radiation therapy)
Goserelin AcetateAlso: ZDX, ZoladexGiven SC	Drug	Treatment (androgen therapy, radiation therapy)
Intensity-Modulated Radiation TherapyAlso: IMRT, Intensity Modulated RT, Intensity-Modulated RadiotherapyUndergo IMRT	Radiation	Treatment (androgen therapy, radiation therapy)
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (androgen therapy, radiation therapy)
Leuprolide AcetateAlso: A-43818, Abbott 43818, Abbott-43818, CarcinilGiven via injection	Drug	Treatment (androgen therapy, radiation therapy)

Primary outcome

Time to Prostate-specific Antigen (PSA) Relapse
Time frame: End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower)
Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to > 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is > 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is > 3.

6 secondary outcomes

Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks.
Time frame: During the time period between on-study PSA to off-study PSA, up to 36 weeks.
Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment).
Time frame: Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks.
Length of Follow-up
Time frame: Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 61.4 months
Count of Patients Remaining Off of Therapy
Time frame: after 36 week LHRH treatment window.
Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes.
Time frame: Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.
CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes.
Time frame: after 36 weeks of LHRH therapy.

Results and safety

Results posted to the registry on 6 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Androgen Therapy, Radiation Therapy)	29	29

Primary outcome: Time to Prostate-specific Antigen (PSA) Relapse

Time frame: End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower). Median (95% Confidence Interval). Unit: month

Measure	Treatment (Androgen Therapy, Radiation Therapy) n = 29
Value	16.5 (14.0 to 34.3)

Population analysed: Metastatic prostate cancer patients treated with androgen deprivation.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Androgen Therapy, Radiation Therapy)	1 of 29 (3.4%)	28 of 29 (96.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cy A Stein principal investigator

City of Hope Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Prostate-specific Antigen (PSA) Relapse (time frame: End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00544830.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.