Clinical trial · Interventional
Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
- 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. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-androgen | Drug | — | UNRESOLVED |
| Brachytherapy | Radiation | — | UNRESOLVED |
| intensity modulated radiotherapy | Radiation | — | UNRESOLVED |
| luteinizing hormone-releasing hormone (LHRH) agonist or antagonist | Drug | — | UNRESOLVED |
| three-dimensional conformal radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1)
- description
- Participants receive androgen deprivation therapy (ADT), consisting of an oral anti androgen plus a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, for a total duration of 4, 6, or 32 months. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the prostate and entire seminal vesicles, delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost to the prostate and proximal seminal vesicles follows, using either IMRT (34.2 Gy in 19 fractions, with protocol specified dose reduction options when indicated) or brachytherapy delivered as low dose rate (LDR) or high dose rate (HDR) implant per protocol.
- interventionNames
- Radiation: three-dimensional conformal radiotherapy
- Radiation: intensity modulated radiotherapy
- Radiation: Brachytherapy
- Drug: Anti-androgen
- Drug: luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
- type
- EXPERIMENTAL
- label
- Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations: * Gleason score 7-10 + T1c-T2b (palpation) + PSA \< 50 ng/ml (includes intermediate and high risk patients); * Gleason score 6 + T2c-T4 (palpation) + PSA \< 50 ng/ml -ORGleason score 6 + ≥ 50% (positive) biopsies + PSA \< 50 ng/ml; * Gleason score 6 + T1c-T2b (palpation) + PSA \> 20 ng/ml. Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure. * History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration. * Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration. * Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm. \*No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute). * Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis. \*Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration. * Study entry PSA should not be obtained during the following time frames: (1) 10- day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride. * Zubrod Performance Status 0-1(unless otherwise specified); * Age ≥ 18; * CBC/differential obtained within 60 days prior to registration on study, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; * Platelets ≥ 100,000 cells/mm3; * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); * Patient must be able to provide study specific informed consent prior to study entry.
References
Publications (0)
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