Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]
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|ClinicalTrials.gov Identifier: NCT03582774|
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Prostate Carcinoma||Drug: 68Ga-PSMA-11||Phase 3|
For men with a recurrence following radical prostatectomy, salvage external beam radiation therapy (SRT) can provide long-term disease control if the recurrence is encompassed within the treatment field and a sufficient radiation dose can be delivered to eradicate the residual/recurrent cancer. SRT offers long-term biochemical control in about 60% of patients. Target volume delineations for prostate cancer SRT after radical prostatectomy are usually drawn in the absence of visibly recurrent disease.
68Ga-PSMA-11 PET/CT detects recurrent prostate cancer with sensitivity superior to standard of care imaging at serum prostate specific antigen (PSA) values low enough to impact routine SRT planning (i.e. <1.0 ng/ml). 68Ga-PSMA-11 PET/CT imaging can improve patient selection for successful SRT by excluding patients with M1 disease where SRT would be futile (extra-pelvic disease is seen in at least 13% of patients with PSA <1.0 ng/ml) and by improving the coverage of the recurrent lesions by the pelvic radiation fields (out-of-field pelvic disease is seen in at least 7% of patients).
This phase III randomized trial aims at showing that 68Ga-PSMA-11 PET/CT improve the success rate of SRT after radical prostatectomy.
Routine care SRT involves either radiotherapy directed to the prostate bed alone, or the prostate bed and pelvic lymph nodes. In addition, the radiotherapy can be delivered either with or without concurrent ADT (typically for 6 months duration of ADT). The choice of treating the prostate bed alone vs prostate bed and pelvic lymph nodes, with or without ADT, is based upon clinico-pathologic features and practice patterns of the treating physician. The treating physician will be asked to describe their general treatment plan prior to randomization.
The treating physician will be encouraged to pursue their general treatment plan after randomization regardless of what arm the patient is randomized into. In some cases, due to specific anatomical features of the patient (for example, location of small bowel), or patient's preference (for example, patient may decline ADT), the general treatment plan may be modified during the radiotherapy planning process. However, the treating physician is encouraged not to use the results of the PSMA PET/CT, if patient receives this scan, to de-escalate therapy. For example, a negative PSMA PET/CT does not mean that the patient has no recurrent prostate cancer. Furthermore, a PSMA PET/CT showing PSMA positive disease in one or more pelvic nodes does not exclude the possibility of additional disease in the prostate bed, and vice versa.
Patients will be followed until either one of the following conditions occur: 5 years after the date of initiation of SRT, Biochemical progression, Diagnostic of metastatic disease, Initiation of any additional, salvage therapy, Death.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||193 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Randomized Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||July 2024|
No Intervention: Arm 1
Patient does not undergo 68Ga-PSMA-11 PET/CT for SRT planning.
Active Comparator: Arm 2
Patient undergoes 68Ga-PSMA-11 PET/CT for SRT planning.
If 68Ga-PSMA-11 PET/CT scan detects PSMA-positive lesions in the pelvis: SRT will be performed per discretion of the treating radiation oncologist. SRT can be performed as routinely planned in accordance with the initial general treatment plan. SRT can also be performed with adapted/extended target volumes to include all pelvic PSMA-positive lesions within the radiation fields. SRT also may be performed with focal dose escalation on the PSMA-positive lesions if feasible. If 68Ga-PSMA-11 PET/CT scan detects PSMA-positive lesions outside the pelvis: treatment management will be performed as per discretion of the treating radiation oncologist. However, the patient will not be included in analysis of the primary endpoint. We assume that approximately 13% of subjects randomized to Arm 2 will be found to be ineligible for SRT and will not be included for further analysis.
- Rate of biochemical progression-free survival [ Time Frame: Time Frame: From date of initiation of salvage radiation therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ]Success rate of SRT measured as biochemical progression-free survival after initiation of SRT. Biochemical progression is defined by PSA ≥ 0.2 ng/mL and rising after completion of SRT
- 5-year progression-free survival rate [ Time Frame: 5 years ]5-year biochemical progression-free survival rate (from date of initiation of SRT)
- Metastasis free-survival [ Time Frame: 5 years ]Diagnostic of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy
- Rate of additional prostate cancer therapy initiation-free survival [ Time Frame: assessed up to 5 years ]From the initiation of salvage radiation therapy until the first documented initiation of any additional prostate cancer treatment
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): NCT03582774
|Contact: Jeannine Gartmann||310-206-0596||jgartmann@MEDNET.UCLA.EDU|
|Contact: Backup Contact||310 206 7372|
|United States, California|
|Los Angeles, California, United States, 90095|
|Contact: J Gartman|
|Principal Investigator:||Jeremie Calais, MD||University of California, Los Angeles|