Clinical trial · Interventional
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
Phase III Multicenter Randomized Trial of Adjuvant Androgen Deprivation in Combination With Three-dimensional Conformal Radiotherapy Doses in High and Intermediate Risk Localized Prostate Cancer.
NCT02175212CI-TRIAL-00048394AADLPCcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The present study is a phase III randomized and multicentric trial evaluating the potential additional impact effect of two years adjuvant androgen deprivation when combined with neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk prostate cancer patients. Stratification will be performed by prognostic factors and by participating institution.
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Long term androgen deprivation | Drug | — | UNRESOLVED |
| Short term androgen deprivation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Long term androgen deprivation
- description
- * Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months) * Bicalutamide 50 mg tablet every day for 2 months * High dose conformal radiotherapy * Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
- interventionNames
- Drug: Long term androgen deprivation
- Radiation: Long term androgen deprivation
- type
- ACTIVE_COMPARATOR
- label
- Short term androgen deprivation
- description
- * Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months) * Bicalutamide 50 mg tablet every day for 2 months * High dose conformal radiotherapy
- interventionNames
- Drug: Short term androgen deprivation
- Radiation: Short term androgen deprivation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proven adenocarcinoma of the prostate * Stage: cT1c-3b N0M0 according to American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) * Prostatic Specific Antigen (PSA)\<100 ng/ml * Intermediate (T1-T2 with Gleason Score \[GS\] 7 and/or PSA 10-20) * High risk (T3 and/or GS 8-10 and/or PSA \> 20) * Karnofsky Index (KI) performance status ≥70% * Written informed consent Exclusion Criteria: * T4 N1 M1, * Previous surgical treatment (prostatectomy or cryosurgery) * Neoadjuvant hormonal treatment \> 3 months. * History of pelvic radiotherapy (RT) * Contraindications for radiotherapy * Concomitant use of chemotherapy * Serious psychiatric or medical condition * Current synchronic malignancies
References
Publications (20)
- BACKGROUNDPollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8. PMID 12128107
- BACKGROUNDZelefsky MJ, Leibel SA, Gaudin PB, Kutcher GJ, Fleshner NE, Venkatramen ES, Reuter VE, Fair WR, Ling CC, Fuks Z. Dose escalation with three-dimensional conformal radiation therapy affects the outcome in prostate cancer. Int J Radiat Oncol Biol Phys. 1998 Jun 1;41(3):491-500. doi: 10.1016/s0360-3016(98)00091-1. PMID 9635694
- BACKGROUNDZelefsky MJ, Fuks Z, Hunt M, Lee HJ, Lombardi D, Ling CC, Reuter VE, Venkatraman ES, Leibel SA. High dose radiation delivered by intensity modulated conformal radiotherapy improves the outcome of localized prostate cancer. J Urol. 2001 Sep;166(3):876-81. PMID 11490237
- BACKGROUNDVicini FA, Abner A, Baglan KL, Kestin LL, Martinez AA. Defining a dose-response relationship with radiotherapy for prostate cancer: is more really better? Int J Radiat Oncol Biol Phys. 2001 Dec 1;51(5):1200-8. doi: 10.1016/s0360-3016(01)01799-0. PMID 11728678
- BACKGROUNDHanks GE, Hanlon AL, Epstein B, Horwitz EM. Dose response in prostate cancer with 8-12 years' follow-up. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):427-35. doi: 10.1016/s0360-3016(02)02954-1. PMID 12243818
- BACKGROUNDLeibel SA, Fuks Z, Zelefsky MJ, Hunt M, Burman CM, Mageras GS, Chui CS, Jackson A, Amols HI, Ling CC. Technological advances in external-beam radiation therapy for the treatment of localized prostate cancer. Semin Oncol. 2003 Oct;30(5):596-615. doi: 10.1016/s0093-7754(03)00354-3. PMID 14571409
- BACKGROUNDJoon DL, Hasegawa M, Sikes C, Khoo VS, Terry NH, Zagars GK, Meistrich ML, Pollack A. Supraadditive apoptotic response of R3327-G rat prostate tumors to androgen ablation and radiation. Int J Radiat Oncol Biol Phys. 1997 Jul 15;38(5):1071-7. doi: 10.1016/s0360-3016(97)00303-9.