Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
Active, enrolledPhase 2Results postedLast updated 7 May 2025
What this trial tests
Phase 2 trial testing Bicalutamide in PSA Level Greater Than Two in 29 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, male only, with PSA Level Greater Than Two or Stage IV Prostate Adenocarcinoma AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Prostate-specific Antigen (PSA) RelapsePrimary· 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.
Group
Value
95% CI
Treatment (Androgen Therapy, Radiation Therapy)
16.5
14.0 – 34.3
Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks.Secondary· During the time period between on-study PSA to off-study PSA, up to 36 weeks.
Number of Patients who achieved PSA nadir of \< 0.2 at 36 weeks.
Group
Value
95% CI
Treatment (Androgen Therapy, Radiation Therapy)
25
Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment).Secondary· Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks.
Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment .
Group
Value
95% CI
Treatment (Androgen Therapy, Radiation Therapy)
15
Length of Follow-upSecondary· 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
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 l
Group
Value
95% CI
Treatment (Androgen Therapy, Radiation Therapy)
111.4
58.1 – 264.8
Count of Patients Remaining Off of TherapySecondary· after 36 week LHRH treatment window.
Patients who remained off of therapy, in remission, out of the number of patients with metastases limited to pelvic lymph nodes.
Group
Value
95% CI
Treatment (Androgen Therapy, Radiation Therapy)
7
Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes.Secondary· 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.
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.
Group
Value
95% CI
Treatment (Androgen Therapy, Radiation Therapy)
14.7
9.2 – 46.4
CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes.Secondary· after 36 weeks of LHRH therapy.
Number of patients remaining in complete remission without androgen deprivation therapy in patients with metastases limited to pelvic lymph nodes.
Group
Value
95% CI
Treatment (Androgen Therapy, Radiation Therapy)
4
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Androgen Therapy, Radiation Therapy)
Serious: 1/29 (3%)
Deaths: —
Serious adverse events (2 terms)
Reaction
System
Treatment (Androgen Therap…
10012727 -- Diarrhea
Gastrointestinal disorders
—
10010300 -- Confusion
Psychiatric disorders
—
Other adverse events (114 terms — click to expand)
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06528210 — Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized
· Phase 2
· withdrawn
NCT06501911 — A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma
· Phase 1
· withdrawn
NCT05327647 — A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
· Phase 2
· recruiting
NCT05050084 — Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 7 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00544830.