Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00423475 |
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Recruitment Status :
Completed
First Posted : January 18, 2007
Last Update Posted : May 17, 2018
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: goserelin acetate Procedure: adjuvant therapy Radiation: radiation therapy | Phase 3 |
OBJECTIVES:
Primary
- Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in terms of biological and/or clinical progression-free survival, in patients who have undergone surgery for recurrent or refractory prostate cancer.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare metastases-free survival of patients treated with these regimens.
- Compare the immediate and delayed toxicities of these regimens.
- Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens.
- Compare the quality of life at 1 and 5 years after radiotherapy in these patients.
- Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over.
OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
- Arm II: Patients undergo radiotherapy as in arm I. Patients also receive goserelin subcutaneously on day 1 and again 3 months later.
Quality of life is assessed periodically.
After completion of study therapy, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 466 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 743 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer |
| Actual Study Start Date : | October 2006 |
| Actual Primary Completion Date : | March 2015 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: I
Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
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Procedure: adjuvant therapy Radiation: radiation therapy |
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Experimental: II
Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
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Drug: goserelin acetate
Other Name: ZOLADEX Procedure: adjuvant therapy Radiation: radiation therapy |
- Progression-free (biological and/or clinical) survival [ Time Frame: 3.5 years ]
- Overall survival [ Time Frame: not yet evaluable ]
- Metastases-free survival [ Time Frame: not yet evaluable ]
- Immediate and delayed toxicities [ Time Frame: not yet evaluable ]
- Delay in reaching the prostate-specific antigen nadir [ Time Frame: not yet evaluable ]
- Quality of life at 1 and 5 years after radiotherapy [ Time Frame: not yet evaluable ]
- Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over [ Time Frame: not yet evaluable ]
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed adenocarcinoma of the prostate
- Localized disease treated with surgery only
- pT2, pT3, or pT4
- pN0 or pNx
- No clinical signs of progressive disease
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Prostate-specific antigen (PSA) meeting the following criteria:
- PSA ≤ 0.1 ng/mL after prostatectomy
- PSA ≥ 0.2 ng/mL and < 2 ng/mL at study entry
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 10 years
- No other cancer in the past 5 years except for treated basal cell skin cancer
- No known pituitary gland adenoma
- No uncontrolled hypertension (i.e., blood pressure ≥ 160 mm Hg systolic and/or 90 mm Hg diastolic)
- No geographical, social, or psychological condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior hormonal therapy
- No prior pelvic radiotherapy
- No prior surgical or chemical castration
- At least 6 months since surgery for biological recurrence
- No other concurrent anticancer therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423475
Show 31 study locations
| Study Chair: | Christian Carrie, MD | Centre Leon Berard |
| Responsible Party: | UNICANCER |
| ClinicalTrials.gov Identifier: | NCT00423475 |
| Other Study ID Numbers: |
GETUG-AFU 16 - UC-0160/0504 EUDRACT-2005-005165-11 CDR0000523446 |
| First Posted: | January 18, 2007 Key Record Dates |
| Last Update Posted: | May 17, 2018 |
| Last Verified: | May 2018 |
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adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer |
stage III prostate cancer recurrent prostate cancer stage IV prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases |
Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Goserelin Antineoplastic Agents, Hormonal Antineoplastic Agents |