Time to Prostate-specific Antigen (PSA) Relapse
| Group | Value (month) |
|---|---|
| Treatment (Androgen Therapy, Radiation Therapy) | 16.5 |
Trial · Interventional
Active, not recruitingPhase 2Results postedRegistry dataUnited States
1 trial · 1 ongoing · 1 with posted results
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
NCT0054483018 Jul 2006 to est. 15 Feb 2027
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Treatment (androgen therapy, radiation therapy)
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.
Outcomes the sponsor listed as primary.
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.
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.
Number of Patients who achieved PSA nadir of \< 0.2 at 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.
Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment .
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
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.
Count of Patients Remaining Off of Therapy
Time frame · 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.
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.
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.
CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes.
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (month) |
|---|---|
| Treatment (Androgen Therapy, Radiation Therapy) | 16.5 |
| Group | Value (Participants) |
|---|---|
| Treatment (Androgen Therapy, Radiation Therapy) | 25 |
| Group | Value (Participants) |
|---|---|
| Treatment (Androgen Therapy, Radiation Therapy) | 15 |
| Group | Value (week) |
|---|---|
| Treatment (Androgen Therapy, Radiation Therapy) | 111.4 |
| Group | Value (Participants) |
|---|---|
| Treatment (Androgen Therapy, Radiation Therapy) | 7 |
| Group | Value (month) |
|---|---|
| Treatment (Androgen Therapy, Radiation Therapy) | 14.7 |
| Group | Value (Participants) |
|---|---|
| Treatment (Androgen Therapy, Radiation Therapy) | 4 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Treatment (Androgen Therapy, Radiation Therapy)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. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection | – | 1 / 29 | 28 / 29 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated