Clinical trial · Interventional
Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antiandrogen | Drug | — | UNRESOLVED |
| Brachytherapy boost | Radiation | — | UNRESOLVED |
| LHRH agonist | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Androgen suppression + EBRT + Brachytherapy
- description
- Androgen suppression with external beam radiation therapy followed by brachytherapy boost
- interventionNames
- Drug: LHRH agonist
- Drug: antiandrogen
- Radiation: radiation therapy
- Radiation: Brachytherapy boost
Primary outcomes (1)
- measure
- Toxicity
- timeFrame
- q 3 mon for 2 yrs post tx initiation
Secondary outcomes (2)
- measure
- Time to PSA failure
- timeFrame
- 6 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Must have one of the following prognostic factors:
* Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score \> 6
* Stage T1-2, N0; PSA \> 10 ng/mL and \< 20 ng/mL; and Gleason score ≤ 6
* Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6
* Prostate volume \< 60 cc by transrectal ultrasound
* No distant or nodal metastases
* No metastatic disease by bone scan, CT scan, or MRI
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic:
* Bilirubin ≤ 1.5 times upper limit of normal
Renal:
* Not specified
Other:
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy for prostate cancer
Chemotherapy:
* No prior chemotherapy for prostate cancer
Endocrine therapy:
* Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy
* No other prior hormonal therapy
Radiotherapy:
* No prior radiotherapy for prostate cancer
Surgery:
* No prior surgery for prostate cancer
* No prior transurethral resection of the prostate
Other:
* No prior alternative therapy (e.g., PC-SPES) for prostate cancerReferences
Publications (2)
- RESULTHurwitz MD, Halabi S, Archer L, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-192, 2010.
- RESULTHurwitz MD, Halabi S, Ou SS, McGinnis LS, Keuttel MR, Dibiase SJ, Small EJ. Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: an initial report of CALGB 99809. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):814-9. doi: 10.1016/j.ijrobp.2008.01.010. Epub 2008 Apr 11. PMID 18407435