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 : Not yet recruiting
First Posted : July 11, 2018
Last Update Posted : July 13, 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.
|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]|
|Estimated Study Start Date :||July 30, 2018|
|Estimated Primary Completion Date :||July 30, 2023|
|Estimated Study Completion Date :||July 2024|
No Intervention: Arm 1
Patient does not undergo 68Ga-PSMA-11 PET/CT for SRT planning. SRT will be performed as routinely planned. Other imaging is allowed if done per routine care.
Active Comparator: Arm 2
Patient undergoes 68Ga-PSMA-11 PET/CT for SRT planning.
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).
- 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: Soosan Roodbari||310-794-1596||SROODBARI@MEDNET.UCLA.EDU|
|Principal Investigator:||Jeremie Calais, MD||University of California, Los Angeles|