Visual Abstract
Abstract
Patients with metastatic prostate cancer are more likely than other groups to present for radiopharmaceutical therapy with urinary incontinence due to complications from prior local prostate cancer treatment. A consequence of urinary incontinence in patients receiving radiopharmaceutical therapy is the potential production of contaminated solid waste, which must be managed by the licensee and, at home, managed by and disposed of by the patient. Prolonging the patient stay in the treating facility after radiopharmaceutical therapy administration, until the first urinary void or potentially overnight, may moderately reduce the quantity of contaminated waste being managed by the patient at home. However, this approach does not fully mitigate the need for a patient waste-management strategy. In this brief communication, the relative radiation safety merits of contaminated waste disposal in the normal household waste stream in comparison to other waste management strategies are evaluated.
When patients with metastatic prostate cancer present for radiopharmaceutical therapy, they are more likely than others to have urinary incontinence due to complications from prior local prostate cancer treatment, including external-beam radiotherapy, permanent-implant low-dose-rate brachytherapy, radical prostatectomy, or some combination of these treatments. Rates of significant urinary incontinence after radiotherapy and radical prostatectomy have been reported to be as high as 52% based on patient-reported outcome surveys (1). After the recent Food and Drug Administration approval of [177Lu]Lu-PSMA-617 (Pluvicto; Novartis Inc.) for treatment of patients with metastatic castration-resistant prostate cancer, a significant increase is expected in the number of patients with urinary incontinence receiving radiopharmaceutical therapy.
Peptide-based radiopharmaceutical therapies, including [177Lu]Lu-PSMA-617, are rapidly excreted from the body primarily by renal elimination into urine. Whole-body elimination of [177Lu]Lu-PSMA-617 is approximately biexponential: on average, 73% of administered activity is eliminated with a half-life of 0.071 d and the remaining 27% is eliminated with a half-life of 1.71 d (2). In a patient with full urinary continence, most of the administered activity will be flushed into municipal wastewater, which is the generally preferred approach to management of such waste. Among such patients, however, a significant fraction of excreted activity may remain as solid contaminated waste (adult diapers, clothing, bed linens, etc.), thereby complicating the issue of waste management. In the case of solid waste that is generated outside the radioactive material licensee’s control (i.e., in the patient’s own home), 3 options exist for waste management. In option A, the patient retains the waste in plastic trash bags in the home until radioactive decay is complete and the waste can be disposed of normally (i.e., as nonradioactive waste). In option B, the patient contains the waste in sanitary trash bags and immediately disposes of it in the normal household waste stream. In option C, the patient retains the waste in plastic trash bags at home and contacts the licensee to arrange waste pickup.
Option C may be logistically intractable for many medical providers. If required, and if fewer centers are able to offer therapy as a result, this approach to waste management could limit patient access to valuable medical care. Therefore, we focus on options A and B as being preferable if radiation risks to the public are sufficiently minimal.
OPTION A: DECAY IN STORAGE
For the scenario in which the patient is instructed to retain waste in the home for decay in storage, the maximally exposed member of the public is likely to be a member of the patient’s household. Cumulative radiation exposure (D) to a household member can be estimated as follows:
Eq. 1where Γ is the exposure rate constant for 177Lu (7.6 μSv m2/GBq h [0.028 mrem m2/mCi h]);
is the activity in the patient as a function of time;
is the occupancy factor of an individual relative to the patient, that is, the fraction of time spent near the patient;
is the distance (m) between the household member and the patient;
is waste activity stored in the house as a function time;
is occupancy factor relative to the waste, that is, the fraction of time spent near the waste; and
is the distance between the household member and the waste.
is approximated by
, where
is the administered activity (typically 7.4 GBq] 200 mCi]),
and
are the fractions of activity administered in the early and late elimination phases (
and
), and
and
are the elimination rate constants (
h−1 and
h−1) (2).
Evaluation of the integral in Equation 1 therefore yields the following:
Eq. 2where W is the fraction of activity excreted in the urine that ends up as contaminated solid waste,
is the total activity excreted by the patient, and
is the physical decay constant for 177Lu (0.004345 h−1).
It can be shown that is calculated as follows:
Eq. 3
This formulation implies that 92.3% of the injected activity is excreted, on average, and 7.7% decays in vivo.
Substituting the result of Equation 3 into Equation 2, and using some reasonable assumptions for occupancy and distance factors (;
= 1 m;
= 1.00;
= 3 m), the estimated exposure to a household member after release of a patient treated with 7.4 GBq (200 mCi) of [177Lu]Lu-PSMA-617 is 249 μSv (24.9 mrem) from activity in the patient and 330 μSv (33.0 mrem) from activity in the waste, resulting in a total estimated exposure of 579 μSv (57.9 mrem) per treatment.
OPTION B: IMMEDIATE WASTE DISPOSAL
For the situation in which a patient with urinary incontinence is instructed to dispose of solid radioactive waste in the ordinary household waste stream with no delay, the radiation exposure to the sanitation worker who collects and transports the waste is of primary relevance. If one assumes that there is, on average, 24 h between waste creation and waste collection, the portion of administered activity that is collected by the sanitation worker is given by , or approximately 83.1% of the administered activity (
). Conservatively assuming that the household member is the individual who transports the waste outside the home for collection, taking 1 min to do so, and keeping all other considerations the same as above, the household member is expected to receive 36 μSv (3.6 mrem) from activity in the waste per treatment.
Assuming negligible radioactive decay during waste transport and an occupancy factor of 1, the radiation exposure to the sanitation worker can be expressed as
Eq. 4where
is the time (h) required to manually collect and empty the waste container into the sanitation truck,
is the distance (m) to the waste during container collection and emptying,
is the time (h) required to transport the waste to a waste facility,
is the distance (m) to the waste during transport, and α is the radiation transmission factor through the adjacent waste and the truck during transport.
The radiation transmission factor (α) can be conservatively estimated using Equation 5 for the approximate steel thickness of a sanitation truck wall (x = ∼0.476 cm [3/16 in]), the mass attenuation coefficient of elemental iron for 208-keV photons ( = 0.143 cm2/g) (3), and the appropriate scatter build-up factor for the relevant energy and number of mean free pathlengths (B = 1.28) (4).
Eq. 5
This transmission estimate is conservative, as it ignores obliquity with respect to the 177Lu γ-rays striking the truck wall, attenuation of lower-energy 177Lu emissions (i.e., 113 keV), and attenuation by waste within the truck.
Some assumptions may be made regarding the time required to collect and transport the waste to a local municipal facility. Collection and transport times ( and
) may be estimated as 30 s (0.0083 h) and 4 h, respectively. Distances from the waste during collection and transport (
and
) may be estimated as 0.25 m and 2.0 m, respectively. Evaluating Equation 4 using these values yields a sanitation worker exposure estimate of 10.3 μSv (1.03 mrem) per patient treatment (assuming
= 7.4 GBq [200 mCi]) or approximately 61.7 μSv (6.2 mrem) for a total of 6 treatments (Atotal = 44.4 GBq [1,200 mCi]).
It is possible that a sanitation worker may provide services to multiple households that have patients undergoing treatment with [177Lu]Lu-PSMA-617. According to the U.S. Bureau of Labor Statistics, approximately 138,700 “refuse and recyclable material collectors” provided services to the approximately 122,354,219 households in the United States in 2021. This implies that each sanitation worker may provide services to 882 households; however, there may be overlap (i.e., waste collection and recycling collection may be provided separately for each household), therefore, to be conservative we can assume that each sanitation worker provides services to 3,000 households.
There are approximately 268,490 new cases of prostate cancer each year in the United States, approximately 5.6% of which (15,035) will present as, or progress to the point of being, metastatic prostate cancer (5). If we assume that all individuals who develop metastatic prostate cancer receive [177Lu]Lu-PSMA-617 and that 24% have urinary incontinence (weighted average from Daugherty et al. (1)), this amounts to a total of 3,608 patients with incontinence from whom sanitation workers might collect waste annually. The per-household probability of having a patient undergoing treatment is therefore 7,818 of 122,354,219, or roughly P = 0.0029% per year. Based on the assumption that individual sanitation workers service 3,000 homes, the probability of encountering N patients in a given year is given by the following binomial probability:
Eq. 6
A conservative estimate of the probability that a sanitation worker will provide services to N patients is therefore as follows: P(0) = 91.7%, P(1) = 7.98%, P(2) = 0.347%, P(3) = 0.010%, P(4) = 0.0002%, and P(5) = 0.000004%.
Based on the calculation result from Equation 4, to exceed the typical regulatory limit of 1 mSv (100 mrem) a sanitation worker would need to provide services to at least 16 homes containing patients receiving [177Lu]Lu-PSMA-617 in a given year. The probability of this occurring is approximately given by
Eq. 7
The number of sanitation workers who would be expected to exceed 100 mrem is therefore .
SUMMARY AND CONCLUSIONS
When a [177Lu]Lu-PSMA-617 patient is incontinent, the expected excess effective dose to a member of the household is expected to be approximately 330 μSv (33 mrem) per 7.4 GBq (200 mCi) of treatment if waste is retained for decay within the household. By comparison, if the waste is disposed of in the normal household waste stream, the maximally exposed sanitation worker is expected to receive approximately 10.3 μSv (1.03 mrem) per 7.4 GBq (200 mCi) of treatment, and the household member exposure is reduced to 36 μSv (3.6 mrem). Therefore, disposal of solid contaminated waste in the normal waste stream results in approximately a 10-fold reduction in estimated household member exposure, with respect to the waste, with only a marginal increase in sanitation worker exposure relative to natural background radiation (∼8 μSv/d [∼0.8 mrem/d]).
The estimated exposures presented here are conservative, and true exposures are likely to be lower, both for decay in storage and for immediate household waste disposal. Household members are unlikely to spend 100% of their time at a distance of 3 m from the radioactive waste. A more conservative estimate might be 50% occupancy at a distance of 5 m, which would reduce exposure by a factor of approximately 5. In the case of a sanitation worker collecting waste, waste receptacle emptying is often automated (not performed by hand), and attenuation within the surrounding waste may be significant, likely more than 1 m of compacted waste, with a density of up to approximately 600 kg/m3. These factors have the potential to decrease sanitation worker exposure by a factor of more than approximately 6. Additionally, the calculations provided in this paper assume immediate release from medical care after [177Lu]Lu-PSMA-617 administration, whereas many patients will void before release, thereby reducing the exposure estimates in both scenarios A and B by approximately 30%. (2) Although not considered in this work, it is also possible that the patient could be catheterized for several days after administration, allowing for urine discharge into the sewage system. Although feasible, and some practices may consider this option, catheterization increases infection risk and reduces patient comfort, thereby potentially reducing the overall quality of care.
Regardless of the conservative nature of these calculations, it seems clear that the pragmatic approach to [177Lu]Lu-PSMA-617 solid-waste management is to instruct patients to contain the waste in sanitary trash bags and to dispose of contaminated waste in the standard household waste stream. This approach is expected to minimize radiation exposure to members of the public, and cumulative exposures are expected to be well below regulatory limits.
DISCLOSURE
No potential conflict of interest relevant to this article was reported.
KEY POINTS
QUESTION: What instructions should be provided to patients regarding contaminated solid waste after administration of [177Lu]Lu-PSMA-617?
PERTINENT FINDINGS: Disposal of contaminated solid waste in the normal municipal waste stream is likely to minimize public radiation exposure, and the exposure received by the maximally exposed sanitation worker is expected to be approximately 10 μSv (∼1 mrem) per administration.
IMPLICATIONS FOR PATIENT CARE: Prostate cancer patients with urinary incontinence can be safely treated, and they do not need to retain contaminated solid waste in their homes.
ACKNOWLEDGMENT
The author acknowledges substantial contributions from Pat B. Zanzonico, including the discussions that inspired this article, as well as his review and revision of the final draft.
Footnotes
Published online Jul. 13, 2023.
- © 2023 by the Society of Nuclear Medicine and Molecular Imaging.
- Received for publication March 17, 2023.
- Revision received May 31, 2023.