Clinical trial · Observational
The AIM Study: Assessing the Impact of Margin Reduction
NCT00754000CI-TRIAL-00006810AIMcompletedClinicalTrials.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)
This study will observe patients who receive external beam radiation for prostate cancer. These patients will be localized and tracked (targeted) with the Calypso 4D Localization System. These patients will have a uniform treatment plan with reduced PTVs (prostate treatment volume) and will be assessed at multiple time points for quality of life and side effects related to radiation therapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- All patients in study
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL
- timeFrame
- 2 year follow-up
Secondary outcomes (4)
- measure
- Collection of patient tracking data from the Calypso 4D Localization System
- timeFrame
- 9 weeks
- measure
- Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are planning to receive external beam radiation of prostate 2. Patients who are to be implanted with Beacon Transponders in the prostate 3. 18 years of age or older. 4. Histologically confirmed diagnosis of prostate cancer. 5. Ability to comply with study visit schedule. 6. Signed informed consent form. Exclusion Criteria: 1. Any patients who have received other investigational therapy within the last 60 days are excluded. 2. Individuals that have previously been implanted with permanent Beacon transponders are excluded. 3. Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip). 4. Any other medical or other condition that would, at the discretion of the investigator, preclude the individual from participation in a clinical study.
References
Publications (16)
- BACKGROUNDPollack A. "The Prostate" in Radiation Oncology: Rationale, Techniques and Results edited by Cox and Ang. Mosby 2003 p 630.
- BACKGROUNDHanks GE, Leibel SA, Krall JM, Kramer S. Patterns of care studies: dose-response observations for local control of adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys. 1985 Jan;11(1):153-7. doi: 10.1016/0360-3016(85)90374-8. PMID 3967982
- BACKGROUNDZelefsky MJ, Fuks Z, Hunt M, Yamada Y, Marion C, Ling CC, Amols H, Venkatraman ES, Leibel SA. High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 772 patients. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6. doi: 10.1016/s0360-3016(02)02857-2. PMID 12128109
- BACKGROUNDZietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233. PMID 16160131
- BACKGROUNDChandra A, Dong L, Huang E, Kuban DA, O'Neill L, Rosen I, Pollack A. Experience of ultrasound-based daily prostate localization. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):436-47. doi: 10.1016/s0360-3016(02)04612-6. PMID 12738318
- BACKGROUNDMichalski JM, Purdy JA, Winter K, Roach M 3rd, Vijayakumar S, Sandler HM, Markoe AM, Ritter MA, Russell KJ, Sailer S, Harms WB, Perez CA, Wilder RB, Hanks GE, Cox JD. Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406. Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):391-402. doi: 10.1016/s0360-3016(99)00443-5. PMID 10661346
- BACKGROUNDRudat V, Schraube P, Oetzel D, Zierhut D, Flentje M, Wannenmacher M. Combined error of patient positioning variability and prostate motion uncertainty in 3D conformal radiotherapy of localized prostate cancer. Int J Radiat Oncol Biol Phys. 1996 Jul 15;35(5):1027-34. doi: 10.1016/0360-3016(96)00204-0.